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U.S. Department of Health and Human Services

Product Classification

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Device oximeter
Regulation Description Oximeter.
Regulation Medical Specialty Cardiovascular
Review Panel Anesthesiology
Product CodeDQA
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 Standards
Guidance Documents
  • Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff
  • General Guidance Document: Non-Invasive Pulse Oximeter [http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM081352.pdf] 
Third Party Review Not Third Party Eligible
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