The following data is part of a premarket notification filed by Carl Zeiss Meditec Ag with the FDA for Qevo System With Kinevo 900.
| Device ID | K170667 |
| 510k Number | K170667 |
| Device Name: | QEVO System With KINEVO 900 |
| Classification | Endoscope, Neurological |
| Applicant | Carl Zeiss Meditec AG Goeschwitzer Strasse 51-52 Jena, DE 07745 |
| Contact | Christian Muenster |
| Correspondent | Calley Herzog Biologics Consulting 400 N. Washington St. Suite 100 Alexandria, VA 22314 |
| Product Code | GWG |
| CFR Regulation Number | 882.1480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-06 |
| Decision Date | 2017-08-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049539072139 | K170667 | 000 |
| 04049539072122 | K170667 | 000 |