The following data is part of a premarket notification filed by Shanghai United Imaging Healthcare Co., Ltd with the FDA for Upmr 790.
Device ID | K192672 |
510k Number | K192672 |
Device Name: | UPMR 790 |
Classification | Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance |
Applicant | Shanghai United Imaging Healthcare Co., Ltd No. 2258 Chengbei Rd, Shanghai, CN 201807 |
Contact | Xin Gao |
Correspondent | Xin Gao Shanghai United Imaging Healthcare Co., Ltd No. 2258 Chengbei Rd, Shanghai, CN 201807 |
Product Code | OUO |
CFR Regulation Number | 892.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-09-26 |
Decision Date | 2019-11-20 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
06971576830084 | K192672 | 000 |