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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 Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Implantable Electrophysical Devices Branch (IEDB)
Submission Type 510(k)
Regulation Number 870.5550
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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