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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Image-Intensified Fluoroscopic X-Ray System, Mobile
510(k) Number K040347
Device Name SIREMOBIL ISO-C 3D
Applicant
Siemens Medical Systems, Inc.
51 Valley Stream Pkwy.
Malvern,  PA  19355 -1406
Applicant Contact NEALIE HARTMAN
Correspondent
Siemens Medical Systems, Inc.
51 Valley Stream Pkwy.
Malvern,  PA  19355 -1406
Correspondent Contact NEALIE HARTMAN
Regulation Number892.1650
Classification Product Code
OXO  
Subsequent Product Code
JAA  
Date Received02/12/2004
Decision Date 03/09/2004
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
Recalls CDRH Recalls
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