Device Classification Name |
system, x-ray, angiographic
|
510(k) Number |
K983877 |
Device Name |
PHILIPS INTEGRIS 3D RA OPTION |
Applicant |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
710 BRIDGEPORT AVE. |
SHELTON,
CT
06484
|
|
Applicant Contact |
PETER ALTMAN |
Correspondent |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
710 BRIDGEPORT AVE. |
SHELTON,
CT
06484
|
|
Correspondent Contact |
PETER ALTMAN |
Regulation Number | 892.1600
|
Classification Product Code |
|
Date Received | 11/02/1998 |
Decision Date | 12/21/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|