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 |