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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 K832996
Device Name SURGICAL IOP MONITOR
Applicant
MIAMI EYE TECHNOLOGY, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
MIAMI EYE TECHNOLOGY, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number886.1930
Classification Product Code
HKY  
Date Received09/02/1983
Decision Date 11/28/1983
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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