The following data is part of a premarket notification filed by Cydar Ltd. with the FDA for Cydar Ev.
| Device ID | K160088 |
| 510k Number | K160088 |
| Device Name: | Cydar EV |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | Cydar Ltd. Bulbeck Mill, Mill Lane Barrington, GB Cb22 7qy |
| Contact | John Clarke |
| Correspondent | Richard A. Vincins Emergo Global Consulting, LLC 816 Congress Avenue, Suite 1400 Austin, TX 78701 |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-15 |
| Decision Date | 2016-07-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060508110002 | K160088 | 000 |