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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
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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