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U.S. Department of Health and Human Services

Product Classification

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Device stethoscope, electronic
Regulation Description Stethoscope.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDQD
Premarket Review Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Submission Type 510(k)
Regulation Number 870.1875
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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