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U.S. Department of Health and Human Services

Product Classification
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Device auxiliary power supply (acor dc) for external transcutaneous cardiac pacemaker
Regulation Description External transcutaneous cardiac pacemaker (noninvasive).
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeMPE
Premarket Review Office of Cardiovascular Devices (OHT2)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Submission Type 510(k)
Regulation Number 870.5550
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? Yes
Third Party Review Not Third Party Eligible
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