Get the free 510(k) premarket notification submission

This document serves as a 510(k) premarket notification for the LOGIQ P9 and LOGIQ P7 ultrasound systems, outlining their intended use, technological specifications, and determination of substantial

How to fill out ge logiq p9 manual pdf form

How to fill out 510(k) premarket notification submission

1. Determine if your device requires a 510(k) by checking its classification.
2. Identify the appropriate predicate device to compare your device against.
3. Gather data on your device, including safety and effectiveness information.
4. Complete the 510(k) form by filling in general device information.
5. Provide a detailed description of the device, including specifications and intended use.
6. Include any performance testing, labeling information, and manufacturing details.
7. Submit your 510(k) along with the required fees and supporting documentation to the FDA.
8. Respond to any additional requests for information from the FDA during the review process.

Who needs 510(k) premarket notification submission?

1. Manufacturers of medical devices that are meant to be marketed in the USA.
2. Companies looking to introduce a new device that is substantially equivalent to an existing device.
3. Device developers who are making modifications to currently marketed devices that require a new 510(k).

People Also Ask about ge logiq e9 user manual pdf

How long does 501k approval take?

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.

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 timeline for 510k submission?

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.

What is the difference between premarket notification and 510k?

These two pathways determine the speed, complexity, and cost of your product's approval. While 510(k) clearance is used for most Class II devices with existing market equivalents, PMA (Premarket Approval) is required for high-risk or entirely novel Class III products.

What are the requirements for 510k premarket notification?

FDA Fact Sheet: Premarket Notification (510(k)) A 510(k) submission must demonstrate that the device is substantially equivalent (SE) to one or more devices legally marketed in the U.S with the same intended use. If the device is found SE by FDA, it is cleared for commercial distribution and may be marketed.

What information is required in a premarket notification submission?

(a) The device name, including both the trade or proprietary name and the common or usual name or classification name of the device. (b) The establishment registration number, if applicable, of the owner or operator submitting the premarket notification submission.

When to submit a new 510k guidance?

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

For pdfFiller’s FAQs

What is 510(k) premarket notification submission?

The 510(k) premarket notification submission is a process through which a medical device manufacturer notifies the FDA of their intent to market a medical device.

Who is required to file 510(k) premarket notification submission?

Any medical device manufacturer that aims to market a device that is not exempt from premarket notification requirements must file a 510(k) submission.

How to fill out 510(k) premarket notification submission?

To fill out a 510(k) submission, manufacturers must provide detailed information regarding the device, including its intended use, technological characteristics, and comparisons to similar devices already on the market.

What is the purpose of 510(k) premarket notification submission?

The purpose of the 510(k) premarket notification submission is to demonstrate that a new medical device is substantially equivalent to a device that is already legally marketed, ensuring safety and effectiveness.

What information must be reported on 510(k) premarket notification submission?

The information that must be reported includes device name, regulatory history, intended use, descriptions of the device, performance data, and comparisons to predicate devices.