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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
STARBOARD MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Incorrect, Inadequate or Imprecise Result or Readings 3
Output Problem 2
Incorrect Measurement 2
Use of Device Problem 1
Electrical /Electronic Property Problem 1
Device Inoperable 1
Defective Component 1
Low Readings 1
Improper Device Output 1
Display or Visual Feedback Problem 1
Erratic or Intermittent Display 1
Unable to Obtain Readings 1
Temperature Sensor 1
Total Device Problems 17


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