The following data is part of a premarket notification filed by Karl Storz Se & Co. Kg with the FDA for Cmos Video Rhino-laryngoscope Ssu.
| Device ID | K192090 |
| 510k Number | K192090 |
| Device Name: | CMOS Video Rhino-Laryngoscope SSU |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | Karl Storz SE & Co. KG Dr.-Karl-Storz-Strasse 34 Tuttlington, DE 78532 |
| Contact | Alexey Davidov |
| Correspondent | Alexey Davidov Karl Storz SE & Co. KG Dr.-Karl-Storz-Strasse 34 Tuttlington, DE 78532 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-05 |
| Decision Date | 2020-01-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551417317 | K192090 | 000 |