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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device electrocardiograph, ambulatory, with analysis algorithm
Product CodeMLO
Regulation Number 870.2800
Device Class 2


Premarket Reviews
ManufacturerDecision
BITTIUM BIOSIGNALS LTD.
  SUBSTANTIALLY EQUIVALENT 1
CARDIOCALM
  SUBSTANTIALLY EQUIVALENT 1
VIVAQUANT INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 1 1
2019 1 1
2021 1 1
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2 2
Patient Data Problem 1 1
Material Rupture 1 1
Date/Time-Related Software Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1 1
No Patient Involvement 1 1
Insufficient Information 1 1
No Clinical Signs, Symptoms or Conditions 1 1

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