The following data is part of a premarket notification filed by Scopis Gmbh with the FDA for Scopis Hybrid Navigation System Em.
| Device ID | K161491 |
| 510k Number | K161491 |
| Device Name: | Scopis Hybrid Navigation System EM |
| Classification | Ear, Nose, And Throat Stereotaxic Instrument |
| Applicant | Scopis GmbH Heinrich-Heine-Platz 10 Berlin, DE 10179 |
| Contact | Christopher Ozbek |
| Correspondent | Roger White Phiama, Inc 236 McKinley Park Lane Louisville, CO 80027 |
| Product Code | PGW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-01 |
| Decision Date | 2017-02-09 |
| Summary: | summary |