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U.S. Department of Health and Human Services

Product Classification

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Device continuous, ventilator, home use
Regulation Description Continuous ventilator.
Definition This product code was needed for the home use indication. CBK is not a tracked device and NOU is a tracked device.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeNOU
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 868.5895
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Recognized Consensus Standards
Implanted Device? No
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible
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