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U.S. Department of Health and Human Services

Product Classification

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Device oximeter, reprocessed
Regulation Description Oximeter.
Definition Same as dqa except reprocessed.
Regulation Medical Specialty Cardiovascular
Review Panel Anesthesiology
Product CodeNLF
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Anesthesiology Devices Branch (ANDB)
Submission Type 510(k)
Regulation Number 870.2700
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Guidance Document
  • Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff
Third Party Review Not Third Party Eligible
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