OTOSCOPE A-34

Otoscope

NEITZ INSTRUMENTS COMPANY, LTD.

The following data is part of a premarket notification filed by Neitz Instruments Company, Ltd. with the FDA for Otoscope A-34.

Pre-market Notification Details

Device IDK950788
510k NumberK950788
Device Name:OTOSCOPE A-34
ClassificationOtoscope
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 CodeERA  
CFR Regulation Number874.4770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-02-21
Decision Date1995-05-03

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.