Anterion
Tomography, Optical Coherence
Heidelberg Engineering GmbH
The following data is part of a premarket notification filed by Heidelberg Engineering Gmbh with the FDA for Anterion.
Pre-market Notification Details
| Device ID | K211817 |
| 510k Number | K211817 |
| Device Name: | Anterion |
| Classification | Tomography, Optical Coherence |
| Applicant | Heidelberg Engineering GmbH Max-Jarecki-Strasse 8 Heidelberg, DE 69115 |
| Contact | Arianna Schoess Vargas |
| Correspondent | Lena Sattler Orasi Consulting, LLC. 226 1st Street Bonita Springs, FL 34134 |
| Product Code | OBO |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-11 |
| Decision Date | 2021-11-05 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04059237000617 | K211817 | 000 |
| 04059237000754 | K211817 | 000 |
| 04059237000877 | K211817 | 000 |
Trademark Results [Anterion]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ANTERION 79222790 5624707 Live/Registered |
Heidelberg Engineering GmbH 2017-10-24 |
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