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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device plethysmograph, pressure
Product CodeCCM
Regulation Number 868.1750
Device Class 2


Premarket Reviews
ManufacturerDecision
VIASYS HEALTHCARE GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 1 1
2020 3 3
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Electrical /Electronic Property Problem 1 1
Failure to Calibrate 1 1
Device Displays Incorrect Message 1 1
Calibration Problem 1 1
Misassembly by Users 1 1
Explosion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 2 2
No Patient Involvement 1 1
Superficial (First Degree) Burn 1 1
Partial thickness (Second Degree) Burn 1 1
Fibrosis 1 1

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