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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name camera, ophthalmic, ac-powered
510(k) Number K972440
Device Name CATARACTSCREENER CT - S
Applicant
NEITZ INSTRUMENTS COMPANY, LTD.
36-13, WAKAMATSU-CHO,
SHINJUKU-KU
TOKYO,  JP 162-0056
Applicant Contact MASAO SUGASAWA
Correspondent
NEITZ INSTRUMENTS COMPANY, LTD.
36-13, WAKAMATSU-CHO,
SHINJUKU-KU
TOKYO,  JP 162-0056
Correspondent Contact MASAO SUGASAWA
Regulation Number886.1120
Classification Product Code
HKI  
Date Received06/30/1997
Decision Date 09/30/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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