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U.S. Department of Health and Human Services

Product Classification

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Device analyzer, pacemaker generator function, indirect
Regulation Description Indirect pacemaker generator function analyzer.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeKRE
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Implantable Electrophysical Devices Branch (IEDB)
Submission Type 510(k)
Regulation Number 870.3640
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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