The following data is part of a premarket notification filed by Medical Intelligence Medizintechnik Gmbh with the FDA for Iguide 2.1.
| Device ID | K143485 |
| 510k Number | K143485 |
| Device Name: | IGuide 2.1 |
| Classification | Accelerator, Linear, Medical |
| Applicant | MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH ROBERT-BOSCH-STRASSE 8 Schwabmunchen, DE 86830 |
| Contact | Michael Wolff |
| Correspondent | Michael Wolff MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH ROBERT-BOSCH-STRASSE 8 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 | 2014-12-08 |
| Decision Date | 2015-03-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056719002190 | K143485 | 000 |
| 04056719002039 | K143485 | 000 |
| 04056719001742 | K143485 | 000 |
| 04056719001704 | K143485 | 000 |
| 04056719001674 | K143485 | 000 |