Pulse Oximeters | 合法醫療器材資訊網

2013年3月4日—FDAhasdevelopedthisguidancedocumenttoassistindustryinpreparingpremarketnotifications(510(k)s)forpulseoximeters.

Docket Number: FDA-2007-D-0205[1] Issued by:

Guidance Issuing Office

Center for Devices and Radiological Health

PDF Printer Version (136 KB)[2]

Document issued on: March 4, 2013

This document supersedes Non-invasive Pulse Oximeter General Guidance Document, September 7, 1992. The draft of this document was issued on July 19, 2007.

For questions regarding this document contact Neel Patel at 301-796-5580 or [email protected][3].

U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Office of Device Evaluation Division of Anest...

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