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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Angiographic
510(k) Number K100468
Device Name ZEISS INFRARED 800 WITH FLOW 800 OPTION
Applicant
Carl Zeiss Surgical GmbH
5160 Hacienda Dr.
Dublin,  CA  94568
Applicant Contact JUDITH BRIMACOMBE
Correspondent
Underwriters Laboratories, Inc.
333 Pfingsten Rd.
Northbrook,  IL  60062
Correspondent Contact NED DEVINE
Regulation Number892.1600
Classification Product Code
IZI  
Date Received02/18/2010
Decision Date 03/03/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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