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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 (PcCO[bdi2]) monitor.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeLKD
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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