光电血氧计FDA认证指导文件.pdf

Pulse Oximeters - Premarket Notification Submissions [510(k)s] Guidance for Industry and Food and Drug Administration Staff 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 neel.patel@. U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Office of Device Evaluation Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices Anesthesiology and Respiratory Devices Branch Contains Nonbinding Recommendations Preface Public Comment You may submit written comments and suggestions at any time for Agency consideration to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, (HFA-305), Rockville, MD, 20852. Submit electronic comments to . Identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register . Comments may not be acted upon by the Agency until the document is next revised or updated. Additional Copies Additional copies are available from the Internet. You may also send an e-mail request to dsmica@ to receive an electronic copy of the guidance or send a fax request to 301- 827-8149 to receive a hard copy. Please use the d