Device Classification Name |
system, x-ray, mobile
|
510(k) Number |
K090322 |
Device Name |
EASY MOVING PLUS, SM-XXHF-YY |
Applicant |
SEDECAL S.A. |
333 MILFORD ROAD |
DEERFIELD,
IL
60015
|
|
Applicant Contact |
DANIEL KAMM |
Correspondent |
SEDECAL S.A. |
333 MILFORD ROAD |
DEERFIELD,
IL
60015
|
|
Correspondent Contact |
DANIEL KAMM |
Regulation Number | 892.1720
|
Classification Product Code |
|
Date Received | 02/09/2009 |
Decision Date | 03/17/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|