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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device airway monitoring system
Definition The device is intended to assist in verifying ett tube placement, assist in detecting ett tube movement and obstruction of the tube tip
Product CodeOQU
Regulation Number 868.5730
Device Class 2


Premarket Reviews
ManufacturerDecision
SONARMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Covidien, LP II Jan-19-2022
2 SonarMed Inc II Sep-04-2019
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