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U.S. Department of Health and Human Services

Product Classification

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Device amplifier and signal conditioner, transducer signal
Regulation Description Transducer signal amplifier and conditioner.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDRQ
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Cardiac Diagnostics Devices Branch (CDDB)
Submission Type 510(k)
Regulation Number 870.2060
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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