The following data is part of a premarket notification filed by Miegmbh with the FDA for Ancoris.
| Device ID | K201807 |
| 510k Number | K201807 |
| Device Name: | ANCORIS |
| Classification | System, Tomography, Computed, Emission |
| Applicant | MiEGmbH Hauptstrasse 112 Seth, DE 23845 |
| Contact | Thomas Kuehl |
| Correspondent | Thomas Kuehl MiEGmbH Hauptstrasse 112 Seth, DE 23845 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-01 |
| Decision Date | 2020-08-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260484140067 | K201807 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ANCORIS 88960472 not registered Live/Pending |
Avent, Inc. 2020-06-11 |
![]() ANCORIS 79373371 not registered Live/Pending |
GROUPE AXTOM 2023-02-07 |