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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Otoscope
510(k) Number K950788
Device Name OTOSCOPE A-34
Applicant
NEITZ INSTRUMENTS COMPANY, LTD.
36-13, WAKAMATSU-CHO,
SHINJUKU-KU
TOKYO,  JP 162-0056
Applicant Contact YASUO KAWANO
Correspondent
NEITZ INSTRUMENTS COMPANY, LTD.
36-13, WAKAMATSU-CHO,
SHINJUKU-KU
TOKYO,  JP 162-0056
Correspondent Contact YASUO KAWANO
Regulation Number874.4770
Classification Product Code
ERA  
Date Received02/21/1995
Decision Date 05/03/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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