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U.S. Department of Health and Human Services

Product Classification

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Device recorder, magnetic tape, medical
Regulation Description Medical magnetic tape recorder.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDSH
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Cardiac Diagnostics Devices Branch (CDDB)
Submission Type 510(k)
Regulation Number 870.2800
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Third Party Review
Accredited Persons

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