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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
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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