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U.S. Department of Health and Human Services

Product Classification

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Device computer, blood-pressure
Regulation Description Blood pressure computer.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDSK
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Cardiac Diagnostics Devices Branch (CDDB)
Submission Type 510(k)
Regulation Number 870.1110
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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