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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 K921255
Device Name PHILIPS BV26 MOBILE C-ARM STAND
Applicant
Philips Medical Systems, Inc.
Veenpluis 4-6
P.O. Box 10000
5680 Da Best,  NL
Applicant Contact WILLIAM MCMAHON
Correspondent
Philips Medical Systems, Inc.
Veenpluis 4-6
P.O. Box 10000
5680 Da Best,  NL
Correspondent Contact WILLIAM MCMAHON
Regulation Number892.1650
Classification Product Code
OXO  
Date Received03/16/1992
Decision Date 05/18/1992
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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