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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Refractometer, Ophthalmic
510(k) Number K945959
Device Name VIDEO VISION ANALYZER (VIVA), VRB 100
Applicant
Tomey Corporation USA
325 Vassar St. 2nd Floor
Cambridge,  MA  02139
Applicant Contact MARK GIRARDI
Correspondent
Tomey Corporation USA
325 Vassar St. 2nd Floor
Cambridge,  MA  02139
Correspondent Contact MARK GIRARDI
Regulation Number886.1760
Classification Product Code
HKO  
Date Received12/07/1994
Decision Date 03/01/1995
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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