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U.S. Department of Health and Human Services

Product Classification

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Device accessory to continuous ventilator (respirator)
Regulation Description Continuous ventilator.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeMOD
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 868.5895
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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