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 |