SCHEPENS-YOSHIDA VIDEO BINOCULAR INDIRECT OPHTHALMSCOPE

Ophthalmoscope, Ac-powered

MIRA, INC.

The following data is part of a premarket notification filed by Mira, Inc. with the FDA for Schepens-yoshida Video Binocular Indirect Ophthalmscope.

Pre-market Notification Details

Device IDK951728
510k NumberK951728
Device Name:SCHEPENS-YOSHIDA VIDEO BINOCULAR INDIRECT OPHTHALMSCOPE
ClassificationOphthalmoscope, Ac-powered
Applicant MIRA, INC. 87 RUMFORD AVE. Waltham,  MA  02453 -3846
ContactRoger R O'brien
CorrespondentRoger R O'brien
MIRA, INC. 87 RUMFORD AVE. Waltham,  MA  02453 -3846
Product CodeHLI  
CFR Regulation Number886.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-04-13
Decision Date1997-03-19

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