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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 K982706
Device Name PHILIPS BV300 SERIES RELEASE 2.1
Applicant
PHILIPS MEDICAL SYSTEMS, INC.
710 BRIDGEPORT AVE.
SHELTON,  CT  06484 -4708
Applicant Contact PETER ALTMAN
Correspondent
PHILIPS MEDICAL SYSTEMS, INC.
710 BRIDGEPORT AVE.
SHELTON,  CT  06484 -4708
Correspondent Contact PETER ALTMAN
Regulation Number892.1650
Classification Product Code
OXO  
Date Received08/04/1998
Decision Date 09/02/1998
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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