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U.S. Department of Health and Human Services

Product Classification

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Device blood pressure cuff
Regulation Description Blood pressure cuff.
Definition A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve(cuff) with a mechanism for inflating the bladder.The cuff is used to determine a subject's blood pressure.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDXQ
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Cardiac Diagnostics Devices Branch (CDDB)
Submission Type 510(k)
Regulation Number 870.1120
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Document
  • Non-Automated Sphygmomanometer (Blood Pressure Cuff) Guidance Version 1; Final
Third Party Review
Accredited Persons

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