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U.S. Department of Health and Human Services

Product Classification

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Device analyzer, gas, carbon-dioxide, partial pressure, blood-phase, indwelling
Regulation Description Indwelling blood carbon dioxide partial pressure (PCO2) analyzer.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeCCC
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 868.1150
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA
Third Party Review
Accredited Persons

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