The following data is part of a premarket notification filed by Medical Intelligence Medizintechnik Gmbh with the FDA for Bodyfix.
Device ID | K013391 |
510k Number | K013391 |
Device Name: | BODYFIX |
Classification | Accelerator, Linear, Medical |
Applicant | MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH FEYERABENDSTRASSE 13-15 Schwabmunchen, DE 86830 |
Contact | Christian Muller |
Correspondent | Christian Muller MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH FEYERABENDSTRASSE 13-15 Schwabmunchen, DE 86830 |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-10-15 |
Decision Date | 2002-01-11 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BODYFIX 77613537 3638909 Dead/Cancelled |
726929 Ontario Ltd. 2008-11-13 |
BODYFIX 73574874 1405063 Dead/Cancelled |
KELLWOOD COMPANY 1985-12-23 |