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U.S. Department of Health and Human Services

Product Classification

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Device unit, liquid-oxygen, portable
Regulation Description Portable liquid oxygen unit.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeBYJ
Premarket Review Opthalmic, Anaesthesia, Respiratory, ENT and Dental Devices (OHT1)
Anethesia, Respiratory, and ENT Devices (DHT1C)
Submission Type 510(k)
Regulation Number 868.5655
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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