Device Classification Name |
System, X-Ray, Angiographic
|
510(k) Number |
K984545 |
Device Name |
RELEASE 2 OF PHILIPS INTEGRIS SERIES (V5000, BV5000, H5000, BH5000, HM2000) SYSTEMS |
Applicant |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
VEENPLUIS 4-6 |
P.O. BOX 10000 |
5680 DA BEST,
NL
5680
|
|
Applicant Contact |
P. ALTMAN |
Correspondent |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
VEENPLUIS 4-6 |
P.O. BOX 10000 |
5680 DA BEST,
NL
5680
|
|
Correspondent Contact |
P. ALTMAN |
Regulation Number | 892.1600
|
Classification Product Code |
|
Date Received | 12/22/1998 |
Decision Date | 02/25/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|