Device Classification Name |
bronchoscope (flexible or rigid)
|
510(k) Number |
K213635 |
Device Name |
Vathin Video Bronchoscope System |
Applicant |
Hunan Vathin Medical Instrument Co., Ltd. |
1/F, Building 12, No.9 Chuanqi West Road, Jiuhua Economic |
Development Zone |
Xiangtan,
CN
411100
|
|
Applicant Contact |
Feng Yun |
Correspondent |
Guangzhou Osmunda Medical Device Technical Service Co., Ltd. |
9th Floor, R&D Building, No.26 Qinglan Street, Panyu |
District |
Gunagzhou,
CN
510006
|
|
Correspondent Contact |
Olivia Meng |
Regulation Number | 874.4680
|
Classification Product Code |
|
Date Received | 11/17/2021 |
Decision Date | 02/28/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|