The following data is part of a premarket notification filed by Hunan Vathin Medical Instrument Co., Ltd. with the FDA for Vathin Video Bronchoscope System.
| Device ID | K213635 |
| 510k Number | K213635 |
| Device Name: | Vathin Video Bronchoscope System |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | Hunan Vathin Medical Instrument Co., Ltd. 1/F, Building 12, No.9 Chuanqi West Road, Jiuhua Economic Development Zone Xiangtan, CN 411100 |
| Contact | Feng Yun |
| Correspondent | Olivia Meng Guangzhou Osmunda Medical Device Technical Service Co., Ltd. 9th Floor, R&D Building, No.26 Qinglan Street, Panyu District Gunagzhou, CN 510006 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-17 |
| Decision Date | 2022-02-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06972197480573 | K213635 | 000 |
| 06972197480566 | K213635 | 000 |