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U.S. Department of Health and Human Services

Product Classification
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Device resuscitator, manual, non self-inflating
Regulation Description Noncontinuous ventilator (IPPB).
Definition A non self-inflating manual resuscitator, also called a hyperinflation system, is a manual ventilator intended to ventilate a patient by forcing a volume of fresh gas into the patient via compression of the ventilator bag; a source of compressed breathing gas is required to inflate the bag.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeNHK
Premarket Review Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Submission Type 510(k)
Regulation Number 868.5905
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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