Device Classification Name |
system, x-ray, mobile
|
510(k) Number |
K042368 |
Device Name |
PRACTIX CONVENIO |
Applicant |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. |
22100 BOTHELL EVERETT HIGHWAY |
BOTHELL,
WA
98021 -8431
|
|
Applicant Contact |
LYNN HARMER |
Correspondent |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. |
22100 BOTHELL EVERETT HIGHWAY |
BOTHELL,
WA
98021 -8431
|
|
Correspondent Contact |
LYNN HARMER |
Regulation Number | 892.1720
|
Classification Product Code |
|
Date Received | 08/31/2004 |
Decision Date | 10/04/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|