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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 expiratory resistance valve, intranasal, for obstructive sleep apnea
Definition Intranasal device that creates expiratory resistance for the treatment of obstructive sleep apnea.
Product CodeOHP
Regulation Number 872.5570
Device Class 2


Premarket Reviews
ManufacturerDecision
BRYGGS MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
INNOMED HEALTHSCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment Of Device Component 1 1
Component Missing 1 1

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

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems II May-29-2020
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