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U.S. Department of Health and Human Services

Product Classification

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Device tent, oxygen, electrically powered
Regulation Description Electrically powered oxygen tent.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeBYK
Premarket Review ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices (DHT1C)
ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices (DHT1C)
Submission Type 510(k)
Regulation Number 868.5710
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? Yes
Third Party Review Not Third Party Eligible
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