The following data is part of a premarket notification filed by Our United Corporation with the FDA for Taichia.
Device ID | K193207 |
510k Number | K193207 |
Device Name: | TaiChiA |
Classification | Accelerator, Linear, Medical |
Applicant | Our United Corporation 3rd Floor, Unit 1, Block 28, ShouChuang International Business Center, NO.66 Xi'an, CN 710018 |
Contact | Qi Liu |
Correspondent | Qi Liu Our United Corporation 3rd Floor, Unit 1, Block 28, ShouChuang International Business Center, NO.66 Xi'an, CN 710018 |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-11-20 |
Decision Date | 2020-08-07 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
TAICHIA 79325993 not registered Live/Pending |
OUR UNITED CORPORATION 2021-06-30 |