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U.S. Department of Health and Human Services

Product Classification
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Device monitor, st segment
Regulation Description Electrocardiograph.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeMLC
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 Standard
Guidance Document
  • Diagnostic ECG Guidance (Including Non-Alarming ST Segment Measurement); Final
Third Party Review
Accredited Persons

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