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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device electrode, ion specific, urea nitrogen
Product CodeCDS
Regulation Number 862.1770
Device Class 2


Premarket Reviews
ManufacturerDecision
EPOCAL INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 2 2
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Display or Visual Feedback Problem 1 1
Incorrect Measurement 1 1
Non Reproducible Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2 2
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Roche Diagnostics Operations, Inc. II Nov-29-2016
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