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U.S. Department of Health and Human Services

Product Classification

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Device pacemaker, cardiac, external transcutaneous (non-invasive)
Regulation Description External transcutaneous cardiac pacemaker (noninvasive).
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDRO
Premarket Review Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
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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