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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device table, cystometric, non-electric and accessories
Regulation Description Urological table and accessories.
Product CodeKQS
Regulation Number 876.4890
Device Class 1


Premarket Reviews
ManufacturerDecision
DORNIER MEDTECH
  SUBSTANTIALLY EQUIVALENT 1
OEC-DIASONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Output, high 2
Device Issue 2
Unintended movement 1
Misassembled by Users 1
Blank screen 1
Failure, intermittent 1
Heat 1
Device remains activated 1
Noise 1
Component missing 1
Total Device Problems 12

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