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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device monitor, airway pressure (includes gauge and/or alarm)
Regulation Description Airway pressure monitor.
Product CodeCAP
Regulation Number 868.2600
Device Class 2


Premarket Reviews
ManufacturerDecision
INSTRUMENTATION INDU
  SUBSTANTIALLY EQUIVALENT 1
VORTRAN MEDICAL TECHNOLOGY 1, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Output Problem 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 4 4

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