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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device camera, ophthalmic, slit-scanning
Regulation Description Ophthalmic camera.
Definition An ophthalmic slit-scanning camera is an AC-powered device intended to take photographs of the eye and the surrounding area.
Product CodeQER
Regulation Number 886.1120
Device Class 2


Premarket Reviews
ManufacturerDecision
CARL ZEISS MEDITEC, INC.
  SUBSTANTIALLY EQUIVALENT 1

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