NEITZ HALOGEN POCKET OPHTHALMOSCOPE A-JR

Ophthalmoscope, Battery-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 Pocket Ophthalmoscope A-jr.

Pre-market Notification Details

Device IDK942719
510k NumberK942719
Device Name:NEITZ HALOGEN POCKET OPHTHALMOSCOPE A-JR
ClassificationOphthalmoscope, Battery-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 CodeHLJ  
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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