Get the free 510(k) Summary 510(k) Number K1 33139 Viztek, LLC - accessdata fda

510(k) Summary 510(k) Number K1 33139 Viziers, LLC. 6491 Powers Avenue APR 9 3 2014 Jacksonville, FL 32217 Phone: 800.366.5343, Fax: 904.448.9936 Date Prepared: February 22, 2014, Contact: Bruce Ashby,

How to fill out 510k summary 510k number

How to fill out 510k summary 510k number:

1. Gather all necessary information and documentation related to the medical device being submitted for 510k clearance.
2. Start by completing the basic information section of the 510k summary, including the company name, device name, intended use, and classification.
3. Provide a detailed description of the device, its components, and how it works. Include information on any similar devices already on the market and highlight any differences or advancements.
4. Explain the intended use of the device and its target population. Provide information on any clinical studies or performance data that support the device's safety and effectiveness.
5. Include information on the device's labeling, such as instructions for use, warnings, and precautions. Make sure to comply with all relevant regulations and guidelines.
6. Address any potential risks or hazards associated with the device and provide a thorough risk assessment. Include information on mitigations and how they have been implemented.
7. Include a summary of any non-clinical testing, such as biocompatibility, sterilization, and electrical safety testing. Provide the testing methods used and results obtained.
8. Summarize any clinical data or studies conducted to demonstrate the device's safety and efficacy. Include details on the study design, patient population, and statistical analysis.
9. Clearly state any proposed indications for use and intended patient population. Provide supporting evidence for these claims, such as clinical data or scientific literature.
10. Review and verify all information provided in the 510k summary for accuracy and completeness. Make sure to follow any specific formatting or submission requirements outlined by the regulatory authorities.

Who needs 510k summary 510k number:

1. Manufacturers or companies developing or modifying medical devices that fall within the scope of the 510k clearance process.
2. Regulatory affairs professionals or consultants responsible for preparing and submitting 510k applications to the appropriate regulatory authorities.
3. Quality assurance personnel involved in ensuring compliance with regulatory requirements for medical devices.
4. Medical device distributors or agents who need to understand the regulatory status and requirements for the devices they handle.
5. Healthcare professionals who may be interested in reviewing the 510k summary to assess the safety and effectiveness of a medical device before recommending its use.
6. Regulatory authorities who review and evaluate the 510k summary as part of the clearance process to determine if the device meets the necessary requirements for market approval.

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