The following data is part of a premarket notification filed by Fiagon Gmbh with the FDA for Fiagon Navigation System.
| Device ID | K133573 |
| 510k Number | K133573 |
| Device Name: | FIAGON NAVIGATION SYSTEM |
| Classification | Ear, Nose, And Throat Stereotaxic Instrument |
| Applicant | FIAGON GMBH NEUENDORFSTRASSE 23B Hennigsdorf, DE 16761 |
| Contact | Dirk Mucha |
| Correspondent | Dirk Mucha FIAGON GMBH NEUENDORFSTRASSE 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 | 2013-11-20 |
| Decision Date | 2014-04-30 |
| Summary: | summary |