NEITZ HALOGEN OPHTHALMOSCOPE BXA-RC

Ophthalmoscope, Ac-powered

NEITZ INSTRUMENTS COMPANY, LTD.

The following data is part of a premarket notification filed by Neitz Instruments Company, Ltd. with the FDA for Neitz Halogen Ophthalmoscope Bxa-rc.

Pre-market Notification Details

Device IDK942715
510k NumberK942715
Device Name:NEITZ HALOGEN OPHTHALMOSCOPE BXA-RC
ClassificationOphthalmoscope, Ac-powered
Applicant NEITZ INSTRUMENTS COMPANY, LTD. 1050 CONNECTICUT AVE., N.W. Washington,  DC 
ContactTracy Berns
CorrespondentTracy Berns
NEITZ INSTRUMENTS COMPANY, LTD. 1050 CONNECTICUT AVE., N.W. Washington,  DC 
Product CodeHLI  
CFR Regulation Number886.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-06-09
Decision Date1994-08-05

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