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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device digital amsler grid
Regulation Description Amsler grid.
Definition A Digital Amsler grid is intended as an aid in detection of central visual irregularities caused by changes in the visual pathway in patients.
Product CodeQTW
Regulation Number 886.1330
Device Class 1


Premarket Reviews
ManufacturerDecision
NEURO-EYE DIAGNOSTIC SYSTEMS LLC
  SUBSTANTIALLY EQUIVALENT 1

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