Get the free MAY 23 2011 510k SUMMARY for EG VI Pro Self Monitoring - accessdata fda

MAY 23, 2011 510(k) SUMMARY for EG VI Pro Self Monitoring Glucose Test System A. Submitter's information EPS BIA Technology Corp. Company: Since Science Park Since City, Taiwan, R.O.C. No. 8, R&D

How to fill out may 23 2011 510k

How to fill out May 23, 2011 510(k):

1. Begin by obtaining the necessary form. The May 23, 2011 510(k) is a specific type of premarket notification form that medical device manufacturers need to complete and submit to the U.S. Food and Drug Administration (FDA).
2. Provide the required general information at the top of the form, including the submitter's name, address, phone number, and email.
3. Identify the manufacturer's name, address, and contact information. This should match the information provided in the establishment registration with the FDA.
4. Specify the proprietary name and intended use of the medical device for which the 510(k) is being filed. Include a brief description of the device and explain how it is similar to or different from any previously cleared devices.
5. Include the medical device's classification information, which helps the FDA determine the level of regulatory control necessary for its approval. This can be found by referring to the FDA's device classification database.
6. Provide a substantial equivalence statement, comparing the new device to a legally marketed device that is already cleared by the FDA. This statement should demonstrate that the new device is as safe and effective as the predicate device.
7. Include any test data or scientific evidence supporting the substantial equivalence claim. This may involve providing information on the device's design, performance, materials, and clinical studies. It's important to include objective and reliable data to strengthen the application.
8. Attach any relevant labeling or user instructions for the device, ensuring that they comply with FDA regulations and guidelines.
9. Prepare a summary of the 510(k) submission, highlighting the key points and conclusions. This summary should convey a clear and concise message regarding the safety and effectiveness of the device.
10. Double-check all the information provided, ensuring its accuracy and completeness. It's a good practice to review the submission multiple times to avoid any errors or omissions.

Who needs May 23, 2011 510(k)?

1. Medical device manufacturers planning to introduce a new device to the U.S. market that does not qualify for an exemption or a different regulatory pathway may need the May 23, 2011 510(k).
2. Manufacturers who have made modifications to an existing device that could significantly affect its safety or efficacy may also require the May 23, 2011 510(k).
3. Companies seeking to obtain clearance for their medical devices from the FDA to ensure compliance with regulatory requirements would benefit from the May 23, 2011 510(k) process.

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What is may 23 510k summary?

The May 23 510(k) summary is a summary of a premarket notification submission to the FDA that demonstrates a medical device is substantially equivalent to a legally marketed device.

Who is required to file may 23 510k summary?

Manufacturers or distributors of medical devices who are seeking FDA approval to market their devices are required to file a 510(k) summary.

How to fill out may 23 510k summary?

The May 23 510(k) summary should be filled out with detailed information about the device, including its intended use, technology, safety, and performance data.

What is the purpose of may 23 510k summary?

The purpose of the May 23 510(k) summary is to demonstrate to the FDA that a new medical device is substantially equivalent to a device that is already legally marketed.

What information must be reported on may 23 510k summary?

The May 23 510(k) summary must include information about the device, its intended use, design, materials, performance data, and any applicable clinical studies.