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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
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