The following data is part of a premarket notification filed by Fiagon Gmbh with the FDA for Fiagon Navigation System.
| Device ID | K151156 |
| 510k Number | K151156 |
| Device Name: | Fiagon Navigation System |
| Classification | Neurological 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 | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-01 |
| Decision Date | 2016-04-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EFIAN012060CUS1 | K151156 | 000 |
| EFIAE012004CUS | K151156 | 000 |
| EFIAN011004MF1 | K151156 | 000 |
| EFIAE012004CUS0 | K151156 | 000 |
| EFIAE012002CUS1 | K151156 | 000 |
| EFIAE012003CUS1 | K151156 | 000 |
| EFIAE012202CUS1 | K151156 | 000 |
| EFIAE012300CUS1 | K151156 | 000 |
| EFIAN012050CUS1 | K151156 | 000 |
| EFIAN012051CUS1 | K151156 | 000 |
| EFIAE011103CUS1 | K151156 | 000 |