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This document is a 510(k) premarket notification summary for the SightSaverm Visual Stimulator, detailing its use as an evoked response photic stimulator for medical personnel in clinical settings,

How to fill out 510k summary sightsaverm visual

How to fill out 510(k) Summary SightSaverm Visual Stimulator K1 13785

1. Gather necessary documentation, including device description, intended use, and labeling information.
2. Prepare a comparison table that outlines the similarities and differences between the SightSaverm Visual Stimulator K1 13785 and a predicate device.
3. Provide safety and effectiveness information based on previous clinical data or performance testing.
4. Complete the FDA Form 3514 for the 510(k) submission.
5. Include any relevant patient and user testing results.
6. Review all content for accuracy and completeness prior to submission.
7. Submit the 510(k) summary to the FDA via the appropriate electronic submission system.

Who needs 510(k) Summary SightSaverm Visual Stimulator K1 13785?

1. Healthcare providers looking to adopt the SightSaverm Visual Stimulator K1 13785 for patient treatment.
2. Medical device distributors and suppliers seeking to stock and sell the product.
3. Regulatory compliance professionals ensuring that the device meets FDA requirements.
4. Clinicians and researchers interested in visual stimulation therapy.

People Also Ask about

What does it mean to be 510 K exempt?

A device may be exempt from 510(k) requirements if the FDA determines that a 510(k) is not required to provide reasonable assurance of safety and effectiveness for the device (see sections 510(l) and 510(m) of the Federal Food, Drug, and Cosmetic (FD&C) Act).

What is Food, Drug and Cosmetic Act Section 510 K?

Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k).

How long will it take my 510 K to be cleared by the US FDA?

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.

What does FDA 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).

What is the Section 510 K of the Federal Food, Drug and Cosmetic Act?

Types of 510(k)s. If your medical device is eligible under premarket notification criteria, there are three types of 510(k)s: Traditional, Abbreviated, and Special. The FDA offers separate checklists for the Traditional, Abbreviated, and Special 510(k)s in its Refuse to Accept Policy for 510(k)s guidance document.

How much does a 510k cost?

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act).

What are the three types of 510k?

On the path to market, a granted de novo request has roughly the same weight as a “cleared” 510(k) submission. Both mean that FDA has opened the door to the market. FDA Approved: This term is reserved for the highest risk “Pre market approval” or PMA devices.

For pdfFiller’s FAQs

What is 510(k) Summary SightSaverm Visual Stimulator K1 13785?

The 510(k) Summary SightSaverm Visual Stimulator K1 13785 is a premarket submission to the FDA that demonstrates that the device is safe and effective for its intended use, comparing it to a legally marketed device.

Who is required to file 510(k) Summary SightSaverm Visual Stimulator K1 13785?

Manufacturers or importers of the SightSaverm Visual Stimulator K1 13785 that wish to market their device in the U.S. are required to file the 510(k) Summary.

How to fill out 510(k) Summary SightSaverm Visual Stimulator K1 13785?

To fill out the 510(k) Summary, one must compile information including the device's name, description, intended use, technological characteristics, and performance data, following the FDA's guidelines.

What is the purpose of 510(k) Summary SightSaverm Visual Stimulator K1 13785?

The purpose of the 510(k) Summary is to provide the FDA with sufficient information to assess whether the device is as safe and effective as a predicate device currently on the market.

What information must be reported on 510(k) Summary SightSaverm Visual Stimulator K1 13785?

The 510(k) Summary must include device identification, indications for use, description of the device, comparisons with predicate devices, summary of safety and efficacy data, and proposed labeling.