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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 K953031
Device Name ZEIMER SELF TONOMETER
Applicant
Cds Technologies
396 Fenton Ln.
P.O. Box 370
W. Chicago,  IL  60186
Applicant Contact GEORGE JOST
Correspondent
Cds Technologies
396 Fenton Ln.
P.O. Box 370
W. Chicago,  IL  60186
Correspondent Contact GEORGE JOST
Regulation Number886.1930
Classification Product Code
HKX  
Date Received05/24/1995
Decision Date 08/22/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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