Device Classification Name |
accelerator, linear, medical
|
510(k) Number |
K121530 |
Device Name |
BODYFIX SYSTEM |
Applicant |
MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH |
Robert-Bosch-Strasse 8 |
SCHWABMUENCHEN,
DE
86830
|
|
Applicant Contact |
MICHAEL WOLFF |
Correspondent |
MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH |
Robert-Bosch-Strasse 8 |
SCHWABMUENCHEN,
DE
86830
|
|
Correspondent Contact |
MICHAEL WOLFF |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 05/24/2012 |
Decision Date | 06/20/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|