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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 Opthalmic, Anaesthesia, Respiratory, ENT and Dental Devices (OHT1)
Anethesia, Respiratory, and ENT 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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