STREAK RETINOSCOPE RX-RP

Retinoscope, 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 Streak Retinoscope Rx-rp.

Pre-market Notification Details

Device IDK950795
510k NumberK950795
Device Name:STREAK RETINOSCOPE RX-RP
ClassificationRetinoscope, Battery-powered
Applicant NEITZ INSTRUMENTS COMPANY, LTD. 36-13, WAKAMATSU-CHO, SHINJUKU-KU Tokyo,  JP 162-0056
ContactYasuo Kawano
CorrespondentYasuo Kawano
NEITZ INSTRUMENTS COMPANY, LTD. 36-13, WAKAMATSU-CHO, SHINJUKU-KU Tokyo,  JP 162-0056
Product CodeHKM  
CFR Regulation Number886.1780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-02-21
Decision Date1995-03-28

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