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U.S. Department of Health and Human Services

Product Classification

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Device analyzer, gas, carbon-dioxide, gaseous-phase
Regulation Description Carbon dioxide gas analyzer.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeCCK
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Submission Type 510(k)
Regulation Number 868.1400
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review
Accredited Persons
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