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U.S. Department of Health and Human Services

Product Classification

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Device analyzer, gas, sevoflurane, gaseous-phase (anesthetic concentration)
Regulation Description Enflurane gas analyzer.
Definition A sevoflurane gas analyzer is a device intended to measure the concentration of sevoflurane anesthetic in a gas mixture
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeNHP
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices (DHT1C)
Submission Type 510(k)
Regulation Number 868.1500
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Recognized Consensus Standard
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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