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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
DEROYAL INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 2 2
2018 1 1
2019 3 3
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Resultor Readings 3 3
Output Problem 3 3
Incorrect Measurement 2 2
Use of Device Problem 1 1
Low Readings 1 1
Improper Device Output 1 1
Compatibility Problem 1 1
Display or Visual Feedback Problem 1 1
Erratic or Intermittent Display 1 1
Unable to Obtain Readings 1 1
Sensing Intermittently 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 2 2
Alteration In Body Temperature 1 1
Foreign Body In Patient 1 1
No Known Impact Or Consequence To Patient 1 1
No Information 1 1
Alteration in Body Temperature 1 1

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