The following data is part of a premarket notification filed by Karl Storz Se & Co. Kg with the FDA for Cmos Video Esophagoscope Ssu.
| Device ID | K192523 |
| 510k Number | K192523 |
| Device Name: | CMOS Video Esophagoscope SSU |
| Classification | Esophagoscope (flexible Or Rigid) |
| Applicant | Karl Storz SE & Co. KG Dr.-Karl-Storz-StraBe 34 Tuttlingen, DE 78532 |
| Contact | Alexey Davidov |
| Correspondent | Alexey Davidov Karl Storz SE & Co. KG Dr.-Karl-Storz-StraBe 34 Tuttlingen, DE 78532 |
| Product Code | EOX |
| CFR Regulation Number | 874.4710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-13 |
| Decision Date | 2020-01-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551417355 | K192523 | 000 |