HYPER Focus
System, Tomography, Computed, Emission
Shanghai United Imaging Healthcare Co.,Ltd.
The following data is part of a premarket notification filed by Shanghai United Imaging Healthcare Co.,ltd. with the FDA for Hyper Focus.
Pre-market Notification Details
| Device ID | K210418 |
| 510k Number | K210418 |
| Device Name: | HYPER Focus |
| Classification | System, Tomography, Computed, Emission |
| Applicant | Shanghai United Imaging Healthcare Co.,Ltd. No. 2258 Chengbei Rd., Jiading Industrial District Shanghai, CN 201807 |
| Contact | Xin Gao |
| Correspondent | Xin Gao Shanghai United Imaging Healthcare Co.,Ltd. No. 2258 Chengbei Rd., Jiading Industrial District Shanghai, CN 201807 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-11 |
| Decision Date | 2021-04-09 |
Trademark Results [HYPER Focus]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HYPER FOCUS 90736612 not registered Live/Pending |
NEURO SUPPLEMENTS LLC 2021-05-26 |
 HYPER FOCUS 90706060 not registered Live/Pending |
Shanghai United Imaging Healthcare Co.,Ltd. 2021-05-12 |
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