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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Perimeter, Ac-Powered
510(k) Number K941723
Device Name WELCH ALLYN GLAUCOMA DETECTOR
Applicant
Welch Allyn, Inc.
4341 State St. Rd.
P.O. Box 220
Skaneateles Falls,  NY  13153
Applicant Contact SCOTT P GUCCIARDI
Correspondent
Welch Allyn, Inc.
4341 State St. Rd.
P.O. Box 220
Skaneateles Falls,  NY  13153
Correspondent Contact SCOTT P GUCCIARDI
Regulation Number886.1605
Classification Product Code
HOO  
Date Received04/07/1994
Decision Date 06/06/1994
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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