PHILIPS INTEGRIS ALLURA


codes

Device Classification Name

interventional fluoroscopic x-ray system

510(k) Number K002016
Device Name PHILIPS INTEGRIS ALLURA
Original Applicant
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
veenpluis 4-6
p.o. box 10000
5680 da best, 

NL

5680

Original Contact peter altman
Regulation Number 892.1650
Classification Product Code
OWB  
Subsequent Product Code
JAA  
Date Received 07/03/2000
Decision Date 09/06/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls