• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
New Search Back To Search Results
Device oximeter, ear
Regulation Description Ear oximeter.
Regulation Medical Specialty Cardiovascular
Review Panel Anesthesiology
Product CodeDPZ
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 870.2710
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
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] 
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible