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U.S. Department of Health and Human Services

Product Classification

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Device tester, pacemaker electrode function
Regulation Description Pacemaker electrode function tester.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDTA
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Implantable Electrophysical Devices Branch (IEDB)
Submission Type 510(k)
Regulation Number 870.3720
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review
Accredited Persons

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