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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device digital visual acuity test
Regulation Description Visual acuity chart.
Definition A Digital visual acuity testing system is intended as an aid in the assessment of visual acuity in patients.
Product CodeQTO
Regulation Number 886.1150
Device Class 1


Premarket Reviews
ManufacturerDecision
VISIBLY, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2026 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Visual Impairment 1 1

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