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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device alarm, blood-pressure
Regulation Description Blood pressure alarm.
Product CodeDSJ
Regulation Number 870.1100
Device Class 2


Premarket Reviews
ManufacturerDecision
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Device operates differently than expected 2
No display or display failure 1
Total Device Problems 3

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