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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ophthalmoscope, Ac-Powered
510(k) Number K930023
Device Name MODEL #12000 BINOCULAR INDERECT OPHTHALMOSCOPE
Applicant
WELCH ALLYN, INC.
4341 STATE ST. RD.
P.O. BOX 220
SKANEATELES FALLS,  NY  13153 -0220
Applicant Contact SCOTT P GUCCIARDI
Correspondent
WELCH ALLYN, INC.
4341 STATE ST. RD.
P.O. BOX 220
SKANEATELES FALLS,  NY  13153 -0220
Correspondent Contact SCOTT P GUCCIARDI
Regulation Number886.1570
Classification Product Code
HLI  
Date Received01/05/1993
Decision Date 06/21/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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