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U.S. Department of Health and Human Services

Product Classification

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Device transducer, ultrasonic
Regulation Description Ultrasonic transducer.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeJOP
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Cardiac Diagnostics Devices Branch (CDDB)
Submission Type 510(k)
Regulation Number 870.2880
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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