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U.S. Department of Health and Human Services

Product Classification

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Device analyzer, gas, halothane, gaseous-phase (anesthetic conc.)
Regulation Description Halothane gas analyzer.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeCBS
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Submission Type 510(k)
Regulation Number 868.1620
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 Standard
Third Party Review
Accredited Persons
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