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U.S. Department of Health and Human Services

Product Classification

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Device adjunctive hemodynamic indicator with decision point
Definition An adjunctive hemodynamic indicator with decision point is a device that identifies and monitors hemodynamic condition(s) of interest and provides notifications at a clinically meaningful decision point. This device is intended to be used adjunctively along with other monitoring and patient information.
Physical State Software
Technical Method Uses analysis of patient data and/or measured vital signs to detect current signs of a hemodynamic condition.
Target Area Cardiovascular system
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeQNV
Premarket Review Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Submission Type 510(k)
Regulation Number 870.2220
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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