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U.S. Department of Health and Human Services

Product Classification

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Device ballistocardiograph
Regulation Description Ballistocardiograph.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDXR
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Cardiac Diagnostics Devices Branch (CDDB)
Submission Type 510(k)
Regulation Number 870.2320
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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