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This document provides a summary of safety and effectiveness information for the CHISON 8300 Digital Ultrasonic Diagnostic Imaging System, submitted for premarket notification under FDA regulations.

How to fill out premarket notification 510k submission

How to fill out Premarket Notification 510(k) Submission

1. Identify the intended use of your device.
2. Determine the appropriate classification for your device.
3. Identify a legally marketed device that is substantially equivalent to your device.
4. Prepare a detailed description of your device, including design, materials, and specifications.
5. Conduct necessary testing to demonstrate safety and effectiveness.
6. Compile an overview of the labeling and packaging for your device.
7. Complete the 510(k) application forms, including the K-number of the predicate device.
8. Gather all relevant documentation, including test data, and finalize your submission.
9. Submit the completed 510(k) submission to the FDA along with any applicable fees.
10. Respond promptly to any requests from the FDA for additional information or clarification.

Who needs Premarket Notification 510(k) Submission?

1. Manufacturers and importers of medical devices intending to market devices that are not exempt from 510(k) requirements.
2. Companies developing new devices that are similar to existing legally marketed devices.

People Also Ask about

When to submit a 510 K premarket notification?

Manufacturers are required to submit a new 510(k) when a change (or changes) exceeds the 21 CFR 807.81(a)(3) threshold, “could significantly affect the safety or effectiveness of the device,” or constitutes a “major change or modification in the intended use of the device.” This significant effect could be positive or

What is the difference between premarket notification and 510k?

The premarket notification 510(k) process requires a medical device manufacturer to 'notify' FDA 90 days before they propose to begin marketing a new or certain modified device. This notification submission allows FDA to determine whether a device is substantially equivalent to one or more predicate devices.

What is the process of pre market approval?

Premarket approval (PMA) is typically required for higher risk Class III medical devices. As part of the PMA application, extensive scientific evidence in the form of laboratory and clinical trial data must be submitted to demonstrate the safety and effectiveness of the device.

What is the pre market notification process?

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 the difference between premarket notification and 510k?

Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.

What is pre-market notification?

Premarket notification is the process through which these new devices claim substantial equivalency to a preexisting device and are automatically classified into the same class as that predicate device.

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What is Premarket Notification 510(k) Submission?

Premarket Notification 510(k) Submission is a regulatory process through which medical device manufacturers must demonstrate that their device is substantially equivalent to a legally marketed device before they can market it in the United States.

Who is required to file Premarket Notification 510(k) Submission?

Manufacturers of medical devices that are not exempt from premarket notification requirements are required to file a 510(k) submission with the FDA.

How to fill out Premarket Notification 510(k) Submission?

To fill out a Premarket Notification 510(k) Submission, manufacturers must complete the FDA's 510(k) form, provide information about the device, its intended use, and demonstrate substantial equivalence to an existing device, along with any required supporting documentation and data.

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

The purpose of Premarket Notification 510(k) Submission is to ensure that new medical devices are safe and effective by comparing them to previously cleared devices, thereby facilitating their entry into the market.

What information must be reported on Premarket Notification 510(k) Submission?

The information required for a Premarket Notification 510(k) Submission includes the device name, intended use, description of the device, labeling, and data that supports its substantial equivalence to another device.