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 | K191828 |
| 510k Number | K191828 |
| 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 | Yun Feng |
| Correspondent | Mike Gu Guangzhou Osmunda Medical Device Technical Service Co., Ltd. 8-9th Floor, R&D Building, N0., 26 Qinglan Street, Panyu District Guangzhou, 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 | 2019-07-08 |
| Decision Date | 2020-02-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06972197480559 | K191828 | 000 |
| 06972197480115 | K191828 | 000 |
| 06972197480108 | K191828 | 000 |
| 06972197480092 | K191828 | 000 |
| 06972197480085 | K191828 | 000 |
| 06972197480078 | K191828 | 000 |
| 06972197480061 | K191828 | 000 |
| 06972197480054 | K191828 | 000 |
| 06972197480047 | K191828 | 000 |
| 06972197480030 | K191828 | 000 |
| 06972197480023 | K191828 | 000 |
| 06972197480122 | K191828 | 000 |
| 06972197480139 | K191828 | 000 |
| 06972197480542 | K191828 | 000 |
| 06972197480535 | K191828 | 000 |
| 06972197480528 | K191828 | 000 |
| 06972197480511 | K191828 | 000 |
| 06972197480191 | K191828 | 000 |
| 06972197480184 | K191828 | 000 |
| 06972197480177 | K191828 | 000 |
| 06972197480160 | K191828 | 000 |
| 06972197480153 | K191828 | 000 |
| 06972197480146 | K191828 | 000 |
| 06972197480016 | K191828 | 000 |