FDA 510(k) Application Details - K982706

Device Classification Name	More FDA Info for this Device
510(K) Number	K982706
Device Name	PHILIPS BV300 SERIES RELEASE 2.1
Applicant	PHILIPS MEDICAL SYSTEMS, INC. 710 BRIDGEPORT AVE. SHELTON, CT 06484-4708 US Other 510(k) Applications for this Company
Contact	PETER ALTMAN Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OXO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/04/1998
Decision Date	09/02/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review