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U.S. Department of Health and Human Services

Product Classification

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Device attachment, intermittent mandatory ventilation (imv)
Regulation Description Intermittent mandatory ventilation attachment.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeCBO
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices (DHT1C)
Submission Type 510(k)
Regulation Number 868.5955
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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