The following data is part of a premarket notification filed by Ikoetech, Llc. with the FDA for Ikoengelo.
| Device ID | K061006 |
| 510k Number | K061006 |
| Device Name: | IKOENGELO |
| Classification | System, Simulation, Radiation Therapy |
| Applicant | IKOETECH, LLC. 3000 RICHMOND, SUITE 200 Houston, TX 77098 |
| Contact | Huimin Chao |
| Correspondent | Huimin Chao IKOETECH, LLC. 3000 RICHMOND, SUITE 200 Houston, TX 77098 |
| Product Code | KPQ |
| Subsequent Product Code | IYE |
| Subsequent Product Code | MUJ |
| CFR Regulation Number | 892.5840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-11 |
| Decision Date | 2006-06-05 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() IKOENGELO 78764960 3406906 Dead/Cancelled |
VARIAN MEDICAL SYSTEMS, INC. 2005-12-01 |