The following data is part of a premarket notification filed by Scivita Medical Technology Co., Ltd. with the FDA for Broncho Videoscope System.
| Device ID | K210379 |
| 510k Number | K210379 |
| Device Name: | Broncho Videoscope System |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | Scivita Medical Technology Co., Ltd. No.8, ZhongTian Xiang, Suzhou Industrial Park Suzhou, CN 215000 |
| Contact | Ruqin Wu |
| Correspondent | Diana Hong Mid-Link Consulting Co.,Ltd P.O.BOX 120-119 Shanghai, CN 200120 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-09 |
| Decision Date | 2021-07-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16971381252382 | K210379 | 000 |
| 16971381254683 | K210379 | 000 |
| 16971381254690 | K210379 | 000 |
| 16971381254706 | K210379 | 000 |
| 16971381254713 | K210379 | 000 |
| 16971381254720 | K210379 | 000 |
| 06971381250473 | K210379 | 000 |
| 06971381250503 | K210379 | 000 |
| 16971381252337 | K210379 | 000 |
| 06971381252347 | K210379 | 000 |
| 16971381252351 | K210379 | 000 |
| 16971381252368 | K210379 | 000 |
| 16971381252375 | K210379 | 000 |
| 16971381254676 | K210379 | 000 |