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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Grid, Amsler
510(k) Number K843702
Device Name APPARATUS & METHODS SELF-EXAM OF EYE
Applicant
Wheel Checkers
2020 S. Bannock St.
Denver ,  CO  80223
Applicant Contact GIESKING
Correspondent
Wheel Checkers
2020 S. Bannock St.
Denver ,  CO  80223
Correspondent Contact GIESKING
Regulation Number886.1330
Classification Product Code
HOQ  
Date Received09/21/1984
Decision Date 01/03/1985
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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