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U.S. Department of Health and Human Services

Product Classification

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Device transducer, pressure, catheter tip
Regulation Description Catheter tip pressure transducer.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDXO
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Cardiac Diagnostics Devices Branch (CDDB)
Submission Type 510(k)
Regulation Number 870.2870
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review
Accredited Persons

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