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U.S. Department of Health and Human Services

Product Classification

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Device transducer, blood-pressure, extravascular
Regulation Description Extravascular blood pressure transducer.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDRS
Premarket Review Office of Cardiovascular Devices (OHT2)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Submission Type 510(k)
Regulation Number 870.2850
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
Third Party Review
Accredited Persons
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