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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 K073087
Device Name NON-CONTACT TONOMETER, MODEL FT-1000
Applicant
Tomey Corporation
2-17-6 Akenbono-Cho
Tachikawa-Shi
Tokyo,  JP 190-0012
Applicant Contact KOJI KUBO
Correspondent
Tomey Corporation
2-17-6 Akenbono-Cho
Tachikawa-Shi
Tokyo,  JP 190-0012
Correspondent Contact KOJI KUBO
Regulation Number886.1930
Classification Product Code
HKX  
Date Received11/01/2007
Decision Date 11/18/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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