Device Classification Name |
System, X-Ray, Fluoroscopic, Image-Intensified
|
510(k) Number |
K050692 |
Device Name |
FLXIS |
Applicant |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. |
22100 BOTHELL EVERETT HWY. |
P.O. BOX 3003 |
BOTHELL,
WA
98041 -3003
|
|
Applicant Contact |
LYNN HARMER |
Correspondent |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. |
22100 BOTHELL EVERETT HWY. |
P.O. BOX 3003 |
BOTHELL,
WA
98041 -3003
|
|
Correspondent Contact |
LYNN HARMER |
Regulation Number | 892.1650
|
Classification Product Code |
|
Date Received | 03/17/2005 |
Decision Date | 04/08/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|