I-SCOPE OPHTHALMIC ENDOSCOPE

Endoilluminator

OPHTHALMIC TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Ophthalmic Technologies, Inc. with the FDA for I-scope Ophthalmic Endoscope.

Pre-market Notification Details

Device IDK971679
510k NumberK971679
Device Name:I-SCOPE OPHTHALMIC ENDOSCOPE
ClassificationEndoilluminator
Applicant OPHTHALMIC TECHNOLOGIES, INC. 37 KODIAK CRESCENT UNIT 16 Downsview, Ontario,  CA M3j 3e5
ContactRichard Weitz
CorrespondentRichard Weitz
OPHTHALMIC TECHNOLOGIES, INC. 37 KODIAK CRESCENT UNIT 16 Downsview, Ontario,  CA M3j 3e5
Product CodeMPA  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-05-07
Decision Date1997-06-25
Summary:summary

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