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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 K181143
Device Name Keeler TonoCare Tonometer
Applicant
Keeler Instruments Inc.
3222 Phoenixville Pike
Malvern,  PA  19355
Applicant Contact Eugene VanArsdale
Correspondent
Keeler Instruments Inc.
3222 Phoenixville Pike
Malvern,  PA  19355
Correspondent Contact Eugene VanArsdale
Regulation Number886.1930
Classification Product Code
HKX  
Date Received05/01/2018
Decision Date 02/08/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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