Device Classification Name |
System, X-Ray, Angiographic
|
510(k) Number |
K910370 |
Device Name |
PHILIPS INTEGRIS V3000 AND V4000 |
Applicant |
PHILIPS MEDICAL SYSTEMS, INC. |
VEENPLUIS 4-6 |
P.O. BOX 10000 |
5680 DA BEST,
NL
|
|
Applicant Contact |
WILLIAM G MCMAHON |
Correspondent |
PHILIPS MEDICAL SYSTEMS, INC. |
VEENPLUIS 4-6 |
P.O. BOX 10000 |
5680 DA BEST,
NL
|
|
Correspondent Contact |
WILLIAM G MCMAHON |
Regulation Number | 892.1600
|
Classification Product Code |
|
Date Received | 01/29/1991 |
Decision Date | 05/28/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|