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U.S. Department of Health and Human Services

Product Classification

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Device analyzer, gas, neon, gaseous-phase
Regulation Description Neon gas analyzer.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeJEF
Premarket Review Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Submission Type 510(k)
Regulation Number 868.1670
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
Third Party Review
Accredited Persons
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