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U.S. Department of Health and Human Services

Product Classification
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Device low patient acuity monitoring system
Regulation Description Cardiac monitor (including cardiotachometer and rate alarm).
Definition For non-continuous central monitoring of patient parameters, including cardiac parameters, in low risk patients.
Physical State electronic software-driven monitor
Technical Method Electronic display at a central monitoring station of monitoring data from patient sensors.
Target Area involves cardiac sensing and other sensor locations on the body
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodePFY
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 Standard
Third Party Review Not Third Party Eligible
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