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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Vein Location, Liquid Crystal
510(k) Number K042679
Device Name IR VIEWER
Applicant
Infrared Imaging Systems, Inc.
1275 Kinnear Rd.
Columbus,  OH  43212
Applicant Contact DALE SIEGEL
Correspondent
Infrared Imaging Systems, Inc.
1275 Kinnear Rd.
Columbus,  OH  43212
Correspondent Contact DALE SIEGEL
Regulation Number880.6970
Classification Product Code
KZA  
Date Received09/29/2004
Decision Date 12/10/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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