Device Classification Name |
System, X-Ray, Mobile
|
510(k) Number |
K111725 |
Device Name |
MOBILEDIAGNOST WDR |
Applicant |
SEDECAL SA |
409 WOODRIDGE DR |
SENECA,
SC
29672
|
|
Applicant Contact |
JENNIFER CARTLEDGE |
Correspondent |
SEDECAL SA |
409 WOODRIDGE DR |
SENECA,
SC
29672
|
|
Correspondent Contact |
JENNIFER CARTLEDGE |
Regulation Number | 892.1720
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/20/2011 |
Decision Date | 07/19/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|