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U.S. Department of Health and Human Services

Product Classification

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Device computer, diagnostic, pre-programmed, single-function
Regulation Description Single-function, preprogrammed diagnostic computer.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDXG
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Cardiac Diagnostics Devices Branch (CDDB)
Submission Type 510(k)
Regulation Number 870.1435
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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