Get the free 10.1.3.2. 510(k) Summary of Safety and Effectiveness Information ... - accessdata fda

... of March 2, 2006. Confidential. DEVICE LISTING FDA FORM 2892: ... 750c-Nnl, 750 cm with MiniMediCO 2-V1 K050844. V Larsen & Tour Limited Star 50 ...

How to fill out 10132 510k summary of

How to fill out 10132 510k summary of:

1. Start by gathering all necessary information and documents related to the medical device for which the 510k summary is being prepared.
2. Read the instructions and guidelines provided by the regulatory authority to understand the requirements for filling out the 10132 510k summary.
3. Begin by entering the basic details of the medical device such as its name, model number, and intended use.
4. Provide a concise summary of the device's technological characteristics and how it functions, including any unique features or innovations.
5. Include a brief description of the materials used in the device's construction and their intended purpose.
6. Clearly outline the device's indications for use, specifying the medical conditions or situations in which it is intended to be used.
7. Include a summary of the device's performance testing, clinical evaluations, and any other relevant data that supports its safety and effectiveness.
8. Describe any potential risks or hazards associated with the device's use and outline the steps taken to mitigate them.
9. Provide a summary of any preclinical or clinical studies conducted to validate the device's performance and safety.
10. Include a list of any similar or predicate devices that have been previously cleared by the regulatory authority.
11. Finally, review and double-check all the information provided in the 10132 510k summary for accuracy and completeness.

Who needs 10132 510k summary of:

1. Medical device manufacturers who intend to market their devices in the United States may need the 10132 510k summary. This summary is a key part of the premarket notification process required by the U.S. Food and Drug Administration (FDA) for most medical devices.
2. Regulatory affairs professionals and consultants involved in preparing and submitting the 510k application may also require the 10132 510k summary.
3. Healthcare professionals, such as physicians or researchers, who are evaluating or conducting studies on medical devices may find the 10132 510k summary useful for understanding the device's intended use, performance, and safety.

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What is 10132 510k summary of?

10132 510k summary is a document that provides a summary of the information submitted to the FDA for a medical device seeking clearance or approval for market.

Who is required to file 10132 510k summary of?

Manufacturers or sponsors of medical devices who are seeking clearance or approval from the FDA are required to file 10132 510k summary.

How to fill out 10132 510k summary of?

To fill out 10132 510k summary, manufacturers or sponsors need to provide detailed information about the medical device, its intended use, indications for use, performance data, and comparisons to similar devices already on the market.

What is the purpose of 10132 510k summary of?

The purpose of 10132 510k summary is to provide a concise overview of the information included in a 510k submission for a medical device. It allows the FDA and other stakeholders to quickly review the key details of the submission.

What information must be reported on 10132 510k summary of?

The 10132 510k summary must include information such as the device description, intended use, indications for use, performance characteristics, and a comparison to similar devices already on the market.