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U.S. Department of Health and Human Services

Product Classification

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Device probe, blood-flow, extravascular
Regulation Description Extravascular blood flow probe.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDPT
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Cardiac Diagnostics Devices Branch (CDDB)
Submission Type 510(k)
Regulation Number 870.2120
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons