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U.S. Department of Health and Human Services

Product Classification

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Device monitor, cardiac (incl. cardiotachometer & rate alarm)
Regulation Description Cardiac monitor (including cardiotachometer and rate alarm).
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDRT
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
Guidance Document
  • Cardiac Monitor Guidance (including Cardiotachometer and Rate Alarm); Final
Third Party Review
Accredited Persons

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