The following data is part of a premarket notification filed by Medical Intelligence Medizintechnik Gmbh with the FDA for Hexapod Evo Rt Couch Top.
| Device ID | K072898 |
| 510k Number | K072898 |
| Device Name: | HEXAPOD EVO RT COUCH TOP |
| Classification | Couch, Radiation Therapy, Powered |
| Applicant | MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH ROBERT-BOSCH-STRASSE 8 Schwabmunchen, DE 86830 |
| Contact | Michael Wolff |
| Correspondent | Stefan Preiss TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | JAI |
| CFR Regulation Number | 892.5770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-10-11 |
| Decision Date | 2007-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056719002244 | K072898 | 000 |
| 04056719001711 | K072898 | 000 |
| 04056719001698 | K072898 | 000 |
| 04056719001681 | K072898 | 000 |
| 04056719001667 | K072898 | 000 |