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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, Stationary
510(k) Number K934005
Device Name SHIMADZU CEILING TUBE SUPPORT CH-30GX
Applicant
Shimadzu Corp.
101 W. Walnut St.
Gardena,  CA  90248
Applicant Contact KIYOSHI KUME
Correspondent
Shimadzu Corp.
101 W. Walnut St.
Gardena,  CA  90248
Correspondent Contact KIYOSHI KUME
Regulation Number892.1680
Classification Product Code
KPR  
Date Received08/18/1993
Decision Date 11/24/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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