The following data is part of a premarket notification filed by Imacor Llc with the FDA for Zura Tee System.
| Device ID | K080223 |
| 510k Number | K080223 |
| Device Name: | ZURA TEE SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | IMACOR LLC 1835 MARKET STREET 28TH FLOOR Philadelphia, PA 19103 |
| Contact | Steven B Datlof M.d., J.d. |
| Correspondent | Steven B Datlof M.d., J.d. IMACOR LLC 1835 MARKET STREET 28TH FLOOR Philadelphia, PA 19103 |
| Product Code | IYO |
| Subsequent Product Code | DXK |
| Subsequent Product Code | ITX |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-29 |
| Decision Date | 2008-06-24 |
| Summary: | summary |