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U.S. Department of Health and Human Services

Product Classification
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Device continuous ventilator, minimal ventilatory support
Definition A continuous ventilator (respirator) for emergency use that is intended to provide minimal ventilatory support to mechanically control or assist patient breathing during declared public health emergency.
Physical State n/a
Technical Method n/a
Target Area n/a
Review Panel Anesthesiology
Product CodeQOR
Premarket Review Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Not Classified Reason EUA - Emergency Use Authorization
Submission Type EUA - Emergency Use Authorization
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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