The following data is part of a premarket notification filed by Imacor Inc with the FDA for Imacor Zura Handheld Zhh-010.
| Device ID | K220490 |
| 510k Number | K220490 |
| Device Name: | ImaCor Zura Handheld ZHH-010 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | ImaCor Inc 50 Jericho Turnpike Suite 105 Jericho, NY 11753 |
| Contact | Richard Lanzillotto |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2022-02-22 |
| Decision Date | 2022-04-08 |