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Call P03M Fingertip Pulse Oximeter FDA 5 10(k) FilesAttachment 3 510(k) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of
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How to fill out attachment 3 510k summary
How to fill out attachment 3 510k summary
01
To fill out attachment 3 510k summary, follow these steps:
02
Begin by providing general information about the device, such as its name, model, and manufacturer.
03
Include details about the intended use and indications for use of the device.
04
Describe the technological characteristics of the device, including its design, components, and materials used.
05
Provide a summary of any clinical, non-clinical, and performance testing conducted on the device.
06
Include information about any previous similar devices that have been cleared or approved by the FDA.
07
Describe any labeling, instructions for use, or packaging materials associated with the device.
08
Discuss any potential risks, hazards, or complications associated with the use of the device.
09
Include information about any post-market surveillance activities or adverse events related to the device.
10
Finally, provide any additional information or documents that support the safety and effectiveness of the device.
Who needs attachment 3 510k summary?
01
Attachment 3 510k summary is required for medical device manufacturers who are seeking clearance or approval from the FDA for their devices.
02
It is an essential part of the 510k submission process and is necessary for demonstrating the safety and effectiveness of the device.
03
Therefore, any medical device manufacturer who wants to market their device in the United States needs to provide an attachment 3 510k summary.
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