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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search Show TPLC since Back To Search Results
Device computer, blood-pressure
Regulation Description Blood pressure computer.
Product CodeDSK
Regulation Number 870.1110
Device Class 2


Premarket Reviews
ManufacturerDecision
ENDOPHYS HOLDINGS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ENDOPHYS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Fluid Leak 77
Leak / Splash 54
Incomplete or Inadequate Connection 6
Monitor 2
Material Separation 2
Device Contamination with Chemical or Other Material 1
Pressure Problem 1
No Device Output 1
Inadequate User Interface 1
Loose or Intermittent Connection 1
Fracture 1
Device Operational Issue 1
Infusion or Flow Problem 1
Missing Test Results 1
No Display / Image 1
Total Device Problems 151


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