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This document is a premarket notification submission for a dental X-ray system, confirming its safety, effectiveness, and substantial equivalence to a predicate device.

How to fill out 510k submission - vex-s

How to fill out 510(k) Submission - VEX-S I100W

1. Gather necessary information about the VEX-S I100W device, including its intended use and technological characteristics.
2. Identify the applicable FDA regulations that pertain to the device.
3. Prepare a summary of the device, including specifications and performance data.
4. Compare the VEX-S I100W to a predicate device that is already FDA-cleared.
5. Compile testing results, including biocompatibility, electrical safety, and performance testing.
6. Complete the FDA 510(k) forms, including all required documentation.
7. Submit the 510(k) application electronically through the FDA's Submitter Portal or via paper submission if required.
8. Pay the required user fee for the 510(k) submission.
9. Respond to any additional information requests from the FDA during the review process.
10. Await FDA's decision and keep records of all communication.

Who needs 510(k) Submission - VEX-S I100W?

1. Manufacturers of the VEX-S I100W who intend to market the device in the U.S.
2. Importers and distributors planning to sell or facilitate the sale of the VEX-S I100W.
3. Any organization or individual that wishes to legally introduce the VEX-S I100W into interstate commerce.

People Also Ask about

How much does it cost to get a product FDA approved?

Consulting Fees for US agent services (typically an annual fee ranging from $250-$1,500) Any additional consulting fees if the FDA contacts your agent. Who is responsible for payment of FDA User Fees ($9,280 for FY 2025 FDA User Fee)

What does FDA granted 510 K clearance mean?

The 510(k) clearance process involves a comprehensive review of safety and performance data for the device, which may include scientific, non-clinical, and clinical data, as appropriate, to determine if a new device is substantially equivalent to a device that is already on the market (that is, a predicate device).

How to find 510k submissions?

The FDA maintains a database of premarket notification 510(k) submissions on its official website, enabling users to search for existing submissions using criteria such as the 510(k) number, applicant, device name or FDA product code.

How much does a 510k submission cost?

How Much Does a FDA 510k Approval Cost? The vast majority of our FDA 510K clients generally spend in the range of $20,000-$30,000 to have their product or device prepared and reviewed before the actual FDA 510k submission process.

How long does a 510 K submission take?

Once the FDA have received your submission, the FDA will officially start the clock on your decision timeline. At the time of writing the FDA states that a traditional 510(k) decision should be provided within 90 days.

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Centrifuge (CFG) Price Today Centrifuge price today is $0.15.

How much does it cost to submit a 510K device?

The vast majority of our FDA 510K clients generally spend in the range of $20,000-$30,000 to have their product or device prepared and reviewed before the actual FDA 510k submission process.

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What is 510(k) Submission - VEX-S I100W?

The 510(k) Submission - VEX-S I100W is a premarket notification submitted to the FDA by manufacturers of medical devices to demonstrate that the device is safe and effective and is substantially equivalent to a legally marketed device.

Who is required to file 510(k) Submission - VEX-S I100W?

Manufacturers or importers of medical devices that intend to market their devices in the U.S. must file a 510(k) Submission - VEX-S I100W if the device is not exempt from this requirement.

How to fill out 510(k) Submission - VEX-S I100W?

To fill out the 510(k) Submission - VEX-S I100W, manufacturers must complete the FDA's 510(k) form, provide device descriptions, compliance with applicable standards, intended use, labeling information, and performance testing results.

What is the purpose of 510(k) Submission - VEX-S I100W?

The purpose of the 510(k) Submission - VEX-S I100W is to obtain FDA clearance to market a medical device by demonstrating that it is safe and effective for its intended use and substantially equivalent to a previously cleared device.

What information must be reported on 510(k) Submission - VEX-S I100W?

On the 510(k) Submission - VEX-S I100W, manufacturers must report device identification, intended use, proposed labeling, summary of technological characteristics, and any data supporting the safety and effectiveness of the device.