Get the free 510(k) summary of Premarket Notification k121468 - accessdata fda

This document provides a 510(k) summary for the Eurotrol GAS-ISE Metabolites and epoc Calibration Verification Fluids, describing their intended use, substantial equivalence, and regulatory classification

How to fill out 510k summary of premarket

How to fill out 510(k) summary of Premarket Notification k121468

1. Identify the device name and the indications for use.
2. Provide a description of the device, including materials and design.
3. Include the device classification and any relevant codes.
4. Summarize the intended use and any technological characteristics.
5. List the predicate device(s) used for comparison.
6. Describe the rationale for the determination of substantial equivalence.
7. Include any performance testing data, including bench, animal, or clinical testing if applicable.
8. Address any safety and effectiveness data supporting the submission.
9. Provide a conclusion on substantial equivalence.
10. Ensure all information is formatted according to FDA guidelines.

Who needs 510(k) summary of Premarket Notification k121468?

1. Manufacturers seeking to market a medical device that is substantially equivalent to an existing device.
2. Companies that are introducing changes or modifications to a previously cleared device.
3. Healthcare professionals or researchers interested in understanding the device's safety and effectiveness information.

People Also Ask about

What is the difference between premarket notification and 510k?

Personal consumption: If you are producing food products for personal consumption and not for distribution or sale, you are exempt from FDA registration. Farms – Facilities that produce, harvest, pack, or hold raw agricultural commodities are exempt from registration.

What does exempt mean in medical coding?

An exempt device, whether it's a class I exempt or a class II exempt device, it doesn't matter. An exempt device is still a regulated medical device. In other words, it meets the code of federal regulations or the CFR definition of a medical device.

What is a 510k premarket notification?

A 510(k) Premarket Notification is required for low to moderate risk medical devices classified as either Class I or Class II and not exempt from 510(k). Companies are unable to market their products to health care providers, patients and other consumers until they are given 510(k) clearance by the FDA.

What is an exemption from the 510k premarket notification requirements?

Most class I and class II devices are exempt from 510(k) requirements. Devices that may be 510(k) exempt include: Preamendment devices (devices legally marketed in the US prior to May 28, 1976) Class I devices specifically exempted by FDA or classified as class I under section 513 (with certain exceptions)

What is 510k exemption for premarket notifications?

510(k) Exempt Manufacturers can bring their devices to market without assurance of safety and effectiveness, but such products are still required to comply with all applicable device regulations, including the Quality System Regulation (QSR).

How long does it take for the 510 K determination in the case of traditional premarket notification?

Generally, 510(k) applicants can expect submission acceptance review decisions within 15 calendar days; substantive review decisions within 60 days; and final decisions within 90 days. Applicants with outstanding review issues will be notified within 100 days.

How to view 510 k submissions?

Users can search the FDA 510(k) database by entering the name of a specific medical device, the name of the applicant who filed the 510(k) premarket notification paperwork for the device, or by entering the specific 510(k) number or product code associated with a given device.

For pdfFiller’s FAQs

What is 510(k) summary of Premarket Notification k121468?

The 510(k) summary of Premarket Notification k121468 is a document submitted to the FDA to demonstrate that a medical device is as safe and effective as a legally marketed device, known as a predicate device. It includes descriptions of the device, intended use, and evidence of substantial equivalence.

Who is required to file 510(k) summary of Premarket Notification k121468?

Manufacturers or sponsors of medical devices intending to market a device in the United States that is not exempt from premarket notification requirements must file a 510(k) summary. This includes new devices and devices that are significantly different from existing ones.

How to fill out 510(k) summary of Premarket Notification k121468?

To fill out the 510(k) summary for k121468, manufacturers must provide detailed information including device description, intended use, labeling, performance testing, and comparisons to predicate devices. It is important to follow the FDA guidelines for submission.

What is the purpose of 510(k) summary of Premarket Notification k121468?

The purpose of the 510(k) summary is to provide the FDA with sufficient information to determine whether the new device is substantially equivalent to an existing device, thus ensuring that it meets safety and effectiveness standards before it can be marketed.

What information must be reported on 510(k) summary of Premarket Notification k121468?

The information that must be reported includes the device name, manufacturer information, intended use, description of the device, comparison to predicate devices, labeling, and results from performance tests, among others.