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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device valve, non-rebreathing
Product CodeCBP
Regulation Number 868.5870
Device Class 2


Premarket Reviews
ManufacturerDecision
FIRSTAR HEALTHCARE COMPANY LIMITED (GUANGZHOU)
  SUBSTANTIALLY EQUIVALENT 1
FISHER & PAYKEL HEALTHCARE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MEDITERA TIBBI MALZEME SAN VE TIC AS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1 1
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1 1
No Clinical Signs, Symptoms or Conditions 1 1

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