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 |