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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device monitor, esophageal motility, anorectal motility, and tube
Regulation Description Gastrointestinal motility monitoring system.
Product CodeKLA
Regulation Number 876.1725
Device Class 2


Premarket Reviews
ManufacturerDecision
GI BIONICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
LABORIE MEDICAL TECHNOLOGIES, CORP.
  SUBSTANTIALLY EQUIVALENT 1
NEURAXIS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1 1
2023 2 2
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 3 3
Device Embedded In Tissue or Plaque 1 1

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