Device Classification Name |
System, X-Ray, Mobile
|
510(k) Number |
K191813 |
Device Name |
MobileDiagnost wDR 2.2 |
Applicant |
Sedecal SA |
C/Pelaya, 9 - 13 Pol. Ind. Rio De Janeiro |
Algete,
ES
28110
|
|
Applicant Contact |
Maria Luisa Gomez De Aguero |
Correspondent |
Laura Green, LLC. |
227 East 284th Street |
Willowick,
OH
44095
|
|
Correspondent Contact |
Laura Green |
Regulation Number | 892.1720
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/05/2019 |
Decision Date | 08/02/2019 |
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
|
|
|