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U.S. Department of Health and Human Services

Product Classification

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Device apparatus, suction, patient care
Regulation Description Patient care suction apparatus.
Regulation Medical Specialty Cardiovascular
Review Panel Anesthesiology
Product CodeDWM
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 870.5050
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Recognized Consensus Standards
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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