Get the free 510 (k) Number: K131309

N 27 2014fhIEhJASECTION 6510(k) Summary 510 (k) Number: K131309 Date of Submission: June 26, 2013, Submitter: BLAMED EQUIPMENTS MEDICOS Agenda Dr. Carlos Burgos 2800 Amparo São Paulo Brazil TEL FAX551938179633

How to fill out 510 k number k131309

How to fill out 510 k number k131309

1. To fill out the 510(k) number k131309, follow these steps:
2. Gather all the necessary information and documents related to the medical device.
3. Download the appropriate 510(k) submission form from the official FDA website.
4. Fill in the required details, such as device description, intended use, and indications for use.
5. Include any supporting data, such as clinical studies or performance evaluations, if applicable.
6. Provide a detailed comparison to a legally marketed device to demonstrate substantial equivalence.
7. Ensure all information is accurate and complete before submitting the 510(k) application.
8. Pay the required user fee as stated by the FDA.
9. Submit the completed 510(k) application and any supporting documents electronically or by mail.
10. Wait for the FDA to review the submission and provide feedback or clearance for market distribution.
11. Follow any additional requirements or recommendations provided by the FDA, if applicable.

Who needs 510 k number k131309?

1. Various entities may need the 510(k) number k131309, including:
2. - Medical device manufacturers who have developed a new or modified medical device.
3. - Companies seeking to market their medical device in the United States.
4. - Individuals or organizations involved in the regulatory affairs of medical devices.
5. - Researchers or scientists conducting studies or experiments related to medical devices.
6. - Regulatory authorities or agencies responsible for assessing the safety and effectiveness of medical devices.
7. Please note that each specific case may have unique requirements, and it is recommended to consult with the FDA or a regulatory expert for complete and accurate information.

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What is 510 k number k131309?

510 k number k131309 is a premarket notification submission made to the FDA for a medical device.

Who is required to file 510 k number k131309?

The manufacturer or distributor of the medical device is required to file the 510 k number k131309.

How to fill out 510 k number k131309?

To fill out the 510 k number k131309, the submitter needs to provide detailed information about the medical device, its intended use, and evidence of its safety and effectiveness compared to a legally marketed device.

What is the purpose of 510 k number k131309?

The purpose of 510 k number k131309 is to demonstrate that the new medical device is substantially equivalent to a legally marketed device and does not need premarket approval.

What information must be reported on 510 k number k131309?

Information such as device description, intended use, comparison to a predicate device, performance testing data, and labeling must be reported on 510 k number k131309.