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SEP232 GE Healthcare 510(k) Premarket Notification Submission 510(k) Summary In accordance with 21 CFR 807.92 the following summary of information is provided: Date: Submitter:July 2l,2011 GE Healthcare

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Ensure that your device is eligible for a new 510k submission.

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Complete the appropriate forms including the FDA 510k template.

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Provide detailed information about the device including its intended use, design, materials, etc.

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Manufacturers of medical devices who are introducing a new device to the market that is not substantially equivalent to an existing device.

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Manufacturers of medical devices that have made significant modifications to an existing device that could affect its safety and effectiveness.

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What is a new 510k?

A new 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device (predicate device).

Who is required to file a new 510k?

Any person who wants to market a new medical device in the United States is required to file a new 510(k) with the FDA.

How to fill out a new 510k?

A new 510(k) submission must include information such as device description, intended use, technological characteristics, performance data, labeling, and any applicable biocompatibility testing results.

What is the purpose of a new 510k?

The purpose of a new 510(k) is to demonstrate to the FDA that the new medical device is substantially equivalent to a legally marketed device.

What information must be reported on a new 510k?

The information that must be reported on a new 510(k) includes device description, intended use, technological characteristics, performance data, labeling, and any applicable biocompatibility testing results.

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