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Respironics Comforted Blue Nasal Mask Premarket Notification — Special 510(k) TAB 3 510(K) SUMMARY OF SAFETY & EFFECTIVENESS Original Date of Submission 14 September 2009 Device Trade Name Common/Usual

People Also Ask about

What is the difference between 510k summary and 510k statement?

The 510(k) summary is similar, in that it is a brief summary of the device and the supporting information, while the 510(k) statement is a certification that the 510(k) holder will provide a copy of the submission to any FDA personnel within 30 days of a written request.

What is the difference between a 510k statement and a summary?

The 510(k) summary is similar, in that it is a brief summary of the device and the supporting information, while the 510(k) statement is a certification that the 510(k) holder will provide a copy of the submission to any FDA personnel within 30 days of a written request.

What is required for FDA 510k summary?

A 510(k) requires demonstration of substantial equivalence to another legally U.S. marketed device. Substantial equivalence means that the new device is as safe and effective as the predicate. the information submitted to FDA demonstrates that the device is as safe and effective as the legally marketed device.

What is needed for a 510k cover letter?

A 510k Cover Letter needs to include the administrative information that is needed to properly identify you, your company, the 510k submission type, applicable regulations, product classification, the review panel, the device product code, and any previous submissions related to this 510k submission.

What is the difference between 510k and FDA approval?

Clearance: What does "FDA cleared" mean? When a medical device is cleared, this means it has undergone a 510(k) submission, which FDA has reviewed and provided clearance. Approval: For Class III medical devices to be legally marketed they must undergo a rigorous review and approval process.

What is 510k submission summary?

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).

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What is 510k summary accessdata fda?

The 510k summary accessdata FDA is a summary document that provides a concise overview of the information included in a 510k submission for a medical device. It contains key information about the device's safety and effectiveness in order to support its clearance for market by the FDA.

Who is required to file 510k summary accessdata fda?

Any manufacturer or distributor who intends to market a medical device in the United States is required to file a 510k summary accessdata FDA.

How to fill out 510k summary accessdata fda?

To fill out a 510k summary accessdata FDA, the manufacturer or distributor needs to provide detailed information about the medical device, including its intended use, technological characteristics, performance data, and any relevant clinical or non-clinical studies. This information must be submitted electronically through the FDA's online portal, following specific formatting and documentation requirements.

What is the purpose of 510k summary accessdata fda?

The purpose of the 510k summary accessdata FDA is to demonstrate to the FDA that a medical device is substantially equivalent to a device already legally marketed in the United States, or that it has undergone the necessary testing and evaluation to ensure its safety and effectiveness for its intended use.

What information must be reported on 510k summary accessdata fda?

The 510k summary accessdata FDA requires various information including device description, intended use, technical specifications, labeling, comparative performance data, risk analysis, biocompatibility, sterility, and clinical data, if applicable.