The following data is part of a premarket notification filed by Shanghai Anqing Medical Instrument Co., Ltd. with the FDA for Bronchoscope System.
| Device ID | K211169 |
| 510k Number | K211169 |
| Device Name: | Bronchoscope System |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | Shanghai AnQing Medical Instrument CO., Ltd. 3&4 Floor, No. 2 Building, 366 Huiqing Road, Zhangjiang High-Tech Park Shanghai, CN 201201 |
| Contact | Shuwen Fan |
| Correspondent | Shuwen Fan Guangzhou Osmunda Medical Device Technical Service Co., Ltd 9th Floor, R&D Building, No. 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 | 2021-04-19 |
| Decision Date | 2021-11-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970034210505 | K211169 | 000 |
| 06970034210390 | K211169 | 000 |
| 06970034210406 | K211169 | 000 |
| 06970034210413 | K211169 | 000 |
| 06970034210420 | K211169 | 000 |
| 06970034210437 | K211169 | 000 |
| 06970034210444 | K211169 | 000 |
| 06970034210451 | K211169 | 000 |
| 06970034210468 | K211169 | 000 |
| 06970034210475 | K211169 | 000 |
| 06970034210482 | K211169 | 000 |
| 06970034210499 | K211169 | 000 |
| 06970034210369 | K211169 | 000 |