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U.S. Department of Health and Human Services

Product Classification

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Device system,network and communication,physiological monitors
Regulation Description Cardiac monitor (including cardiotachometer and rate alarm).
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeMSX
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Cardiac Diagnostics Devices Branch (CDDB)
Submission Type 510(k)
Regulation Number 870.2300
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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