Device Classification Name |
system, x-ray, angiographic
|
510(k) Number |
K902542 |
Device Name |
PHILIPS INTEGRIS C2000 SYSTEM |
Applicant |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
710 BRIDGEPORT AVE. |
SHELTON,
CT
06484
|
|
Applicant Contact |
WILLIAM G MCMAHON |
Correspondent |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
710 BRIDGEPORT AVE. |
SHELTON,
CT
06484
|
|
Correspondent Contact |
WILLIAM G MCMAHON |
Regulation Number | 892.1600
|
Classification Product Code |
|
Date Received | 06/06/1990 |
Decision Date | 08/17/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|