The following data is part of a premarket notification filed by Somatex Medical Technologies Gmbh with the FDA for Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-shape.
| Device ID | K201863 |
| 510k Number | K201863 |
| Device Name: | Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape |
| Classification | Marker, Radiographic, Implantable |
| Applicant | SOMATEX Medical Technologies GmbH Hohenzollerndamm 150/151 Berlin, DE 14199 |
| Contact | David Vasmer |
| Correspondent | David Vasmer SOMATEX Medical Technologies GmbH Hohenzollerndamm 150/151 Berlin, DE 14199 |
| Product Code | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-06 |
| Decision Date | 2021-02-18 |