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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 K993947
Device Name KOORDINANT ANGIOGRAPHIC AND OPERATING ROOM MODEL X-RAY TABLE FAMILY
Applicant
Siemens Corp.
186 Wood Ave. S.
Iselin,  NJ  08830
Applicant Contact ALICIA JUERGENSEN
Correspondent
Siemens Corp.
186 Wood Ave. S.
Iselin,  NJ  08830
Correspondent Contact ALICIA JUERGENSEN
Regulation Number892.1600
Classification Product Code
IZI  
Date Received11/22/1999
Decision Date 12/21/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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