Get the free pg I of4 510(k) Summary 510(k) Number: K130579 1 - accessdata fda

Pg I of4 510(k) Summary 510(k) Number: K130579 1. Submitter Information Submitter Name: Physician Software Systems, LL1C 3333 Greenville Road, Suite 200 Lisle, Illinois 60532 Phone: 3312139000 Fax:

How to fill out pg i of4 510k

How to fill out pg i of4 510k:

1. Start by providing the necessary identification information at the top of the page, including the submitter's name, contact information, and the FDA Establishment Registration Number.
2. Next, fill in the name, contact information, and FDA Establishment Registration Number of the manufacturer, as well as the Address of Record.
3. Specify the 510(k) number, along with the intended use of the device, and the product code as assigned by the FDA.
4. Describe the technological characteristics of the device, including its design, composition, and performance specifications.
5. Indicate any applicable standards or recognized consensus standards used in the evaluation of the device.
6. If the device relies on software or firmware, provide details on the operating system, intended functions, and any associated hardware.
7. Include information on the device's labeling, such as instructions for use, warnings, and precautions.
8. If the device has any accessories or components, provide a detailed description of each and their relationship to the main device.
9. Document any testing, verification, or validation conducted on the device, including test methods, results, and a summary of the data.
10. Provide a summary and conclusion on the overall safety and effectiveness of the device, addressing any potential risks or issues.
11. Finally, sign and date the form, along with any required certifications or statements.

Who needs pg i of4 510k:

1. Manufacturers or submitters seeking clearance from the FDA for certain medical devices might require pg i of4 510(k).
2. Individuals or organizations involved in the development, production, or distribution of medical devices that qualify for 510(k) clearance may need pg i of4 510(k).
3. Regulatory affairs professionals or consultants responsible for preparing and submitting the 510(k) application on behalf of the manufacturer or submitter could require pg i of4 510(k).
4. Quality assurance personnel or compliance officers ensuring that the 510(k) application is completed accurately and in compliance with FDA regulations might need pg i of4 510(k).
5. Any other relevant stakeholders involved in the process of obtaining FDA clearance for medical devices may be required to have pg i of4 510(k) as part of the application.

For pdfFiller’s FAQs

What is pg i of4 510k?

The pg i of4 510k is a section of the FDA Form 510(k) used for submitting premarket notifications for medical devices.

Who is required to file pg i of4 510k?

Manufacturers or distributors of medical devices are required to file pg i of4 510k with the FDA before introducing their product to the market.

How to fill out pg i of4 510k?

Pg i of4 510k should be filled out with detailed information about the medical device, its intended use, technological characteristics, and any similarities to previously cleared devices.

What is the purpose of pg i of4 510k?

The purpose of pg i of4 510k is to demonstrate to the FDA that the medical device is substantially equivalent to a legally marketed device and does not present a new safety or effectiveness concern.

What information must be reported on pg i of4 510k?

Information such as device description, intended use, technological characteristics, performance data, and labeling must be reported on pg i of4 510k.

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