The following data is part of a premarket notification filed by Imacor Inc. with the FDA for Zura Tee System With Claritee Probe.
| Device ID | K100989 |
| 510k Number | K100989 |
| Device Name: | ZURA TEE SYSTEM WITH CLARITEE PROBE |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | IMACOR INC. 50 CHARLES LINDBERGH BLVD SUITE 200 Uniondale, NY 11553 |
| Contact | Richard Lanzillotto |
| Correspondent | Richard Lanzillotto IMACOR INC. 50 CHARLES LINDBERGH BLVD SUITE 200 Uniondale, NY 11553 |
| 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 | No |
| Combination Product | No |
| Date Received | 2010-04-09 |
| Decision Date | 2010-06-25 |
| Summary: | summary |