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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stethoscope, esophageal, with electrical conductors
Regulation Description Esophageal stethoscope with electrical conductors.
Product CodeBZT
Regulation Number 868.1920
Device Class 2


Premarket Reviews
ManufacturerDecision
COVIDIEN, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 3 3
2022 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Covidien LLC II May-29-2026
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