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U.S. Department of Health and Human Services

Product Classification
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Device non-invasive central venous manometer
Regulation Description Venous blood pressure manometer.
Definition Measures the central venous blood pressure (CVP) non-invasively at the superior vena cava (right heart) based on near infrared spectroscopy (NIRS) technology.
Physical State display unit, sensor cable, and adhesive sensor patches
Technical Method Uses near infrared spectroscopy (NIRS) technology to measure blood flow between the neck location and the reference location
Target Area Applied to skin on neck to measure CVP
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodePFA
Premarket Review Office of Cardiovascular Devices (OHT2)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Submission Type 510(k)
Regulation Number 870.1140
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
Third Party Review Not Third Party Eligible
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