NIDEK DIGITAL KERATOMETER

Intraocular Lens

NIDEK, INC.

The following data is part of a premarket notification filed by Nidek, Inc. with the FDA for Nidek Digital Keratometer.

Pre-market Notification Details

Device IDK842892
510k NumberK842892
Device Name:NIDEK DIGITAL KERATOMETER
ClassificationIntraocular Lens
Applicant NIDEK, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeHQL  
CFR Regulation Number886.3600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-07-23
Decision Date1984-10-05

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