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U.S. Department of Health and Human Services

Product Classification

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Device electrocardiograph
Regulation Description Electrocardiograph.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDPS
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Cardiac Diagnostics Devices Branch (CDDB)
Submission Type 510(k)
Regulation Number 870.2340
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Document
  • Diagnostic ECG Guidance (Including Non-Alarming ST Segment Measurement); Final
Third Party Review
Accredited Persons

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