Device Classification Name |
system, x-ray, mobile
|
510(k) Number |
K101517 |
Device Name |
SEDECAL MOBILE DIGITAL DIAGNOSTIC X-RAY |
Applicant |
SEDECAL S.A. |
8870 RAVELLO CT |
NAPLES,
FL
34114
|
|
Applicant Contact |
DANIEL KAMM, P.E. |
Correspondent |
SEDECAL S.A. |
8870 RAVELLO CT |
NAPLES,
FL
34114
|
|
Correspondent Contact |
DANIEL KAMM, P.E. |
Regulation Number | 892.1720
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/02/2010 |
Decision Date | 08/05/2011 |
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
|
|
|