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U.S. Department of Health and Human Services

Product Classification

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Device analyzer, gas, oxygen, gaseous-phase
Regulation Description Oxygen gas analyzer.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeCCL
Premarket Review Opthalmic, Anaesthesia, Respiratory, ENT and Dental Devices (OHT1)
Anethesia, Respiratory, and ENT Devices (DHT1C)
Submission Type 510(k)
Regulation Number 868.1720
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Recognized Consensus Standards
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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