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U.S. Department of Health and Human Services

Product Classification
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Device ventilator, external body, negative pressure, adult (cuirass)
Regulation Description External negative pressure ventilator.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeBYT
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Submission Type 510(k)
Regulation Number 868.5935
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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