FDA 510(k) Application Details - K002840

Device Classification Name	System, X-Ray, Angiographic   More FDA Info for this Device
510(K) Number	K002840
Device Name	System, X-Ray, Angiographic
Applicant	THE PHANTOM LABORATORY, INC. 2727 STATE ROUTE 29 GREENWICH, NY 12834 US Other 510(k) Applications for this Company
Contact	JOSHUA R LEVY Other 510(k) Applications for this Contact
Regulation Number	892.1600   More FDA Info for this Regulation Number
Classification Product Code	IZI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/12/2000
Decision Date	11/17/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review