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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ophthalmoscope, battery-powered
Product CodeHLJ
Regulation Number 886.1570
Device Class 2


Premarket Reviews
ManufacturerDecision
AMERICAN DIAGNOSTIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
HEINE OPTOTECHNIK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
HEINE OPTOTECHNIK GMBH & CO. KG.
  SUBSTANTIALLY EQUIVALENT 3
MEDICAL DEVICES (PVT) LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1 1
2022 2 2
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Thermal Decomposition of Device 2 2
Fire 2 2
Overheating of Device 1 1
Sparking 1 1
Explosion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3
No Known Impact Or Consequence To Patient 1 1

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