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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 Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Submission Type 510(k)
Regulation Number 870.2300
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Guidance Document
Third Party Review
Accredited Persons
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