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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 Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Division of Anesthesia, Respiratory, and Sleep 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
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review
Accredited Persons
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