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 |