This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. Pulse Oximeters - Premarket Notification Submissions : Guidance for Industry and Food and Drug Administration Staff
11.1 Identification of Components and Uses.Submissions for Reprocessed Single-Use Sensors.Cleaning, Disinfection, and Sterilization.Electrical, Mechanical, and Environmental Safety.4.4 Saturation pulse information signal.4.3 Display values, outputs, and indicators.Please use the document number 1605 to identify the guidance you are requesting. You may also send an e-mail request to to receive a copy of the guidance. Additional CopiesĪdditional copies are available from the Internet. Comments may not be acted upon by the Agency until the document is next revised or updated.
Identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register. 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. The draft of this document was issued on July 19, 2007.įor questions regarding this document contact Neel Patel at 30 or Department of Health and Human Servicesĭivision of Anesthesiology, General Hospital,Īnesthesiology and Respiratory Devices BranchĬontains Nonbinding Recommendations Preface Public Comments This document supersedes Non-invasive Pulse Oximeter General Guidance Document, September 7, 1992. Center for Devices and Radiological Health
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