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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device apparatus, gas-scavenging
Regulation Description Gas-scavenging apparatus.
Product CodeCBN
Regulation Number 868.5430
Device Class 2


Premarket Reviews
ManufacturerDecision
SEDATION SYSTEMS LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 1 1
2020 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Premature Discharge of Battery 1 1
Material Integrity Problem 1 1
Device Operates Differently Than Expected 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2 2
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Maquet Cardiovascular Us Sales, Llc II Feb-27-2015
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