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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tonometer, Ac-Powered
510(k) Number K111710
Device Name FULL AUTO TONOMETER MODEL TX-20
Applicant
Canon Inc. -Medical Equipment Group
C/O Cosmos Corporation
3f 2-17-6 Akebono-Cho
Tachikawa-Shi, Tokyo,  JP 190-0012
Applicant Contact KOJI KUBO
Correspondent
Canon Inc. -Medical Equipment Group
C/O Cosmos Corporation
3f 2-17-6 Akebono-Cho
Tachikawa-Shi, Tokyo,  JP 190-0012
Correspondent Contact KOJI KUBO
Regulation Number886.1930
Classification Product Code
HKX  
Date Received06/20/2011
Decision Date 09/20/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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