The following data is part of a premarket notification filed by Veran Medical Technologies, Inc. with the FDA for Spin Vision Video Bronchoscope System.
| Device ID | K202346 |
| 510k Number | K202346 |
| Device Name: | SPiN Vision Video Bronchoscope System |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | Veran Medical Technologies, Inc. 1908 Innerbelt Business Center Dr St. Louis, MO 63114 |
| Contact | B. Nathan Hunt |
| Correspondent | B. Nathan Hunt Veran Medical Technologies, Inc. 1908 Innerbelt Business Center Dr St. Louis, MO 63114 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-18 |
| Decision Date | 2021-02-19 |