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U.S. Department of Health and Human Services

Product Classification
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Device apparatus, electronanesthesia
Regulation Description Electroanesthesia apparatus.
Definition Call for PMAs 12/26/96 (61 FR 50706 (9/27/96))
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeBWL
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Submission Type PMA
Regulation Number 868.5400
Device Class 3
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 Not Third Party Eligible
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