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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Medical Examination, Ac Powered
510(k) Number K920103
Device Name EPISCOPE, MODEL 47300
Applicant
Welch Allyn, Inc.
4341 State St. Rd.
P.O. Box 220
Skaneateles Falls,  NY  13153
Applicant Contact JOHN WATKINS
Correspondent
Welch Allyn, Inc.
4341 State St. Rd.
P.O. Box 220
Skaneateles Falls,  NY  13153
Correspondent Contact JOHN WATKINS
Regulation Number880.6320
Classification Product Code
KZF  
Date Received01/09/1992
Decision Date 04/28/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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