Device Classification Name |
System, X-Ray, Mobile
|
510(k) Number |
K033238 |
Device Name |
MOBILETTE XP AND MOBILETT XPHYBRID |
Applicant |
SIEMENS MEDICAL SYSTEMS, INC. |
51 VALLEY STREAM PARKWAY |
MALVERN,
PA
19355 -1406
|
|
Applicant Contact |
NEALIE HARTMAN |
Correspondent |
SIEMENS MEDICAL SYSTEMS, INC. |
51 VALLEY STREAM PARKWAY |
MALVERN,
PA
19355 -1406
|
|
Correspondent Contact |
NEALIE HARTMAN |
Regulation Number | 892.1720
|
Classification Product Code |
|
Date Received | 10/06/2003 |
Decision Date | 11/14/2003 |
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
|
|
|