RETINA TESTER

K914393 · Retina Tester · HLX · Mar 2, 1992 · Ophthalmic

Device Facts

Record IDK914393
Device NameRETINA TESTER
ApplicantRetina Tester
Product CodeHLX · Ophthalmic
Decision DateMar 2, 1992
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 886.1630
Device ClassClass 2

Regulatory Classification

Identification

An AC-powered photostimulator is an AC-powered device intended to provide light stimulus which allows measurement of retinal or visual function by perceptual or electrical methods (e.g., stroboscope).

Innolitics

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