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U.S. Department of Health and Human Services

Product Classification

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Device monitor, carbon-dioxide, cutaneous
Regulation Description Cutaneous carbon dioxide (PcCO2) monitor.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeLKD
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)
Regulation Number 868.2480
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
Third Party Review Not Third Party Eligible
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