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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 K933564
Device Name SKYTRON EXAM LIGHT
Applicant
Skytron, Div. the Kmw Group, Inc.
5000 36th St. SE
P.O.Box 888615
Grand Rapids,  MI  49588
Applicant Contact DAVID M MEHNEY
Correspondent
Skytron, Div. the Kmw Group, Inc.
5000 36th St. SE
P.O.Box 888615
Grand Rapids,  MI  49588
Correspondent Contact DAVID M MEHNEY
Regulation Number880.6320
Classification Product Code
KZF  
Date Received07/22/1993
Decision Date 02/10/1994
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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