ELECTRORETINOGRAPH

Electrode, Corneal

LKC TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Lkc Technologies, Inc. with the FDA for Electroretinograph.

Pre-market Notification Details

Device IDK760199
510k NumberK760199
Device Name:ELECTRORETINOGRAPH
ClassificationElectrode, Corneal
Applicant LKC TECHNOLOGIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeHLZ  
CFR Regulation Number886.1220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1976-07-07
Decision Date1976-08-04

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