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U.S. Department of Health and Human Services

Product Classification

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Device monitor, oxygen, cutaneous, for infant not under gas anesthesia
Regulation Description Cutaneous oxygen (PcO2) monitor.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeKLK
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Respiratory Devices Branch (RPDB)
Submission Type 510(K) Exempt
Regulation Number 868.2500
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Guidance Document
  • Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCo2) and Oxygen (PcO2) Monitors; Guidance for Industry and FDA
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons