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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tonometer, Manual
510(k) Number K172728
Device Name Applanation tonometer AT-1
Applicant
Takagi Seiko Co., Ltd.
330-2
Nakano-Shi,  JP 383-8585
Applicant Contact Shinya Kitamura
Correspondent
Takagi Seiko Co., Ltd.
330-2
Nakano-Shi,  JP 383-8585
Correspondent Contact Shinya Kitamura
Regulation Number886.1930
Classification Product Code
HKY  
Date Received09/11/2017
Decision Date 10/17/2017
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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