The following data is part of a premarket notification filed by Cydar Ltd. with the FDA for Cydar Ev (series B) And Cydar Ev Maps.
| Device ID | K212442 |
| 510k Number | K212442 |
| Device Name: | Cydar EV (Series B) And Cydar EV Maps |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | Cydar Ltd. Bulbeck Mill, Mill Lane Barrington, GB Cb22 7qy |
| Contact | Vanisha Mistry |
| Correspondent | Rob Hague Cydar Ltd. Bulbeck Mill, Mill Lane Barrington, GB Cb22 7qy |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-04 |
| Decision Date | 2021-12-03 |