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U.S. Department of Health and Human Services

Product Classification
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Device patient monitor with independent remote display and operation
Definition Monitors intended for the remote display and operation of patient physiological monitors, including alarm functionality, signal analysis, and data recording during declared public health emergency.
Physical State Patient monitor with screen for remote display and operation
Technical Method Connects to the main monitor through a wired network
Target Area The remote monitor provides display and operation of physiological measurements which the primary monitor is capable of monitoring.
Review Panel Cardiovascular
Product CodeQLJ
Premarket Review Office of Cardiovascular Devices (OHT2)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Not Classified Reason EUA - Emergency Use Authorization
Submission Type EUA - Emergency Use Authorization
Device Class Not Classified
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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