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U.S. Department of Health and Human Services

Product Classification

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Device amplifier and signal conditioner, biopotential
Regulation Description Biopotential amplifier and signal conditioner.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDRR
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Interventional Cardiology Devices Branch (ICDB)
Submission Type 510(k)
Regulation Number 870.2050
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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