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U.S. Department of Health and Human Services

Product Classification

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Device stethoscope, esophageal, with electrical conductors
Regulation Description Esophageal stethoscope with electrical conductors.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeBZT
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 868.1920
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? No
Third Party Review
Accredited Persons
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