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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device antimicrobial blood pressure cuff
Regulation Description Blood pressure cuff.
Definition Device is a replacement cuff to be used in conjunction with a non-invasive blood pressure monitor. Together the devices determine blood pressures and heart rate. This particular cuff contains an embedded antimicrobial. 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.
Product CodeOED
Regulation Number 870.1120
Device Class 2


Premarket Reviews
ManufacturerDecision
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1

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