Device Classification Name |
esophagoscope (flexible or rigid)
|
510(k) Number |
K192523 |
Device Name |
CMOS Video Esophagoscope SSU |
Applicant |
Karl Storz SE & Co. KG |
Dr.-Karl-Storz-StraBe 34 |
Tuttlingen,
DE
78532
|
|
Applicant Contact |
Alexey Davidov |
Correspondent |
Karl Storz SE & Co. KG |
Dr.-Karl-Storz-StraBe 34 |
Tuttlingen,
DE
78532
|
|
Correspondent Contact |
Alexey Davidov |
Regulation Number | 874.4710
|
Classification Product Code |
|
Date Received | 09/13/2019 |
Decision Date | 01/24/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|