Get the free 510(k) Summary as required by section 21 CFR 807

2821CNWUMAR510(k) Summary as required by section 21 CFR 807.92(c) 21 CFR 807.92(a)(1) Submitter Name:Conned Corporation Viking SystemsSubmitter Address:525 French Road Utica, NY 13502Contact Person:Nancy

How to fill out 510k summary as required

How to fill out 510k summary as required

1. To fill out the 510k summary as required, follow these steps:
2. Begin by entering the basic details of the device, such as its name, classification, and intended use.
3. Provide a brief description of the device's technological characteristics, including its design and components.
4. Summarize any preclinical or clinical testing that has been conducted on the device, including study objectives, methods, and results.
5. Include information on any similar devices on the market and how your device differs from them.
6. Discuss any potential risks associated with the device and how you plan to mitigate them.
7. Provide a summary of the labeling and instructions for use that will accompany the device.
8. Finally, include any additional information that may be relevant to the evaluation of the device's safety and effectiveness.
9. Ensure that your 510k summary is clear, concise, and well-organized, and follow any specific formatting or submission guidelines provided by the regulatory authority.

Who needs 510k summary as required?

1. Any medical device manufacturer or distributor who wishes to market a new medical device in the United States and seeks approval from the U.S. Food and Drug Administration (FDA) needs to provide a 510k summary as required.
2. This summary is required as part of the 510(k) premarket notification process, which allows the FDA to evaluate whether the new device is substantially equivalent to a legally marketed device and can be marketed without further clinical testing.
3. Therefore, any company or individual seeking FDA clearance for a new medical device needs to include a 510k summary as required by the regulatory process.

For pdfFiller’s FAQs

How do I edit 510k summary as required in Chrome?

Download and install the pdfFiller Google Chrome Extension to your browser to edit, fill out, and eSign your 510k summary as required, which you can open in the editor with a single click from a Google search page. Fillable documents may be executed from any internet-connected device without leaving Chrome.

Can I sign the 510k summary as required electronically in Chrome?

As a PDF editor and form builder, pdfFiller has a lot of features. It also has a powerful e-signature tool that you can add to your Chrome browser. With our extension, you can type, draw, or take a picture of your signature with your webcam to make your legally-binding eSignature. Choose how you want to sign your 510k summary as required and you'll be done in minutes.

How do I fill out 510k summary as required on an Android device?

Use the pdfFiller Android app to finish your 510k summary as required and other documents on your Android phone. The app has all the features you need to manage your documents, like editing content, eSigning, annotating, sharing files, and more. At any time, as long as there is an internet connection.

What is 510k summary as required?

510k summary is a summary of the safety and effectiveness information about a medical device that is submitted to the FDA for clearance.

Who is required to file 510k summary as required?

Manufacturers of medical devices are required to file 510k summary as required.

How to fill out 510k summary as required?

To fill out 510k summary, manufacturers need to provide detailed information about the device, its intended use, and its safety and effectiveness data.

What is the purpose of 510k summary as required?

The purpose of 510k summary is to demonstrate that a medical device is safe and effective for its intended use before it can be marketed in the United States.

What information must be reported on 510k summary as required?

The information reported on 510k summary must include device description, intended use, safety and effectiveness data, and any relevant clinical studies.