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U.S. Department of Health and Human Services

Product Classification

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Device reprocessed blood pressure cuff
Regulation Description Blood pressure cuff.
Definition The intended use for the reprocessed/reused blood pressure cuff is use in manual measurement and automatic non-invasive blood pressure monitoring by properly trained personnel.Complete inflation systems are designed for use with manometers during manual bp measurement.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeNPP
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
Third Party Review Not Third Party Eligible
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