Device Classification Name |
System, X-Ray, Angiographic
|
510(k) Number |
K023441 |
Device Name |
PHILIPS MULTIDIAGNOST ELEVA |
Applicant |
PHILIPS MEDICAL SYSTEMS |
4-6 VEENPLUIS, P.O. BOX 1000 |
BEST,
NL
5680 DA
|
|
Applicant Contact |
LYNN HARMER |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
1655 SCOTT BLVD. |
SANTA CLARA,
CA
95050
|
|
Correspondent Contact |
LYNN HARMER |
Regulation Number | 892.1600
|
Classification Product Code |
|
Date Received | 10/15/2002 |
Decision Date | 10/30/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|