WOODLYN CLASSIC JAVAL OPHTHALMOMETER

Ophthalmoscope, Ac-powered

WOODLYN, INC.

The following data is part of a premarket notification filed by Woodlyn, Inc. with the FDA for Woodlyn Classic Javal Ophthalmometer.

Pre-market Notification Details

Device IDK841764
510k NumberK841764
Device Name:WOODLYN CLASSIC JAVAL OPHTHALMOMETER
ClassificationOphthalmoscope, Ac-powered
Applicant WOODLYN, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeHLI  
CFR Regulation Number886.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-04-27
Decision Date1984-08-07

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.