Device Classification Name |
nasopharyngoscope (flexible or rigid)
|
510(k) Number |
K192090 |
Device Name |
CMOS Video Rhino-Laryngoscope SSU |
Applicant |
Karl Storz SE & Co. KG |
Dr.-Karl-Storz-Strasse 34 |
Tuttlington,
DE
78532
|
|
Applicant Contact |
Alexey Davidov |
Correspondent |
Karl Storz SE & Co. KG |
Dr.-Karl-Storz-Strasse 34 |
Tuttlington,
DE
78532
|
|
Correspondent Contact |
Alexey Davidov |
Regulation Number | 874.4760
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/05/2019 |
Decision Date | 01/27/2020 |
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
|