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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
CONTEC MEDICAL SYSTEM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GALIX BIOMEDICAL INSTRUMENTATION, INC.
  SUBSTANTIALLY EQUIVALENT 1
INOVISE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
LABTECH KFT.
  SUBSTANTIALLY EQUIVALENT 1
NORAV MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
VALES & HILLS BIOMEDICAL TECH. LTD.
  SUBSTANTIALLY EQUIVALENT 1
VIVAQUANT INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1 1
2017 1 1
2018 1 1
2019 1 1
2021 1 1
2022 1 1
2023 1 1
2024 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 2 2
Data Problem 1 1
Signal Artifact/Noise 1 1
Product Quality Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Material Rupture 1 1
Date/Time-Related Software Problem 1 1
Device Operates Differently Than Expected 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Insufficient Information 1 1
Tachycardia 1 1
No Consequences Or Impact To Patient 1 1
No Patient Involvement 1 1

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