The following data is part of a premarket notification filed by Fiagon Gmbh with the FDA for Cube Navigation System, Virtueye V2, Navigation Sensor Nanorest, Navigation Unit Cube 4d.
| Device ID | K211291 |
| 510k Number | K211291 |
| Device Name: | Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D |
| Classification | Ear, Nose, And Throat Stereotaxic Instrument |
| Applicant | Fiagon GmbH Neuendorfstr. 23b Hennigsdorf, DE 16761 |
| Contact | Dirk Mucha |
| Correspondent | Dirk Mucha Fiagon GmbH Neuendorfstr. 23b Hennigsdorf, DE 16761 |
| Product Code | PGW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-28 |
| Decision Date | 2021-07-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EFIAE0114301 | K211291 | 000 |
| 04260759930126 | K211291 | 000 |