The following data is part of a premarket notification filed by Shenzhen Anke High-tech Co., Ltd. with the FDA for Mri Sytems.
| Device ID | K113281 |
| 510k Number | K113281 |
| Device Name: | MRI SYTEMS |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | SHENZHEN ANKE HIGH-TECH CO., LTD. P.O. BOX 237-023 Shanghai, CN 200237 |
| Contact | Diana Hong |
| Correspondent | Marc Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-11-07 |
| Decision Date | 2012-05-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06950743801058 | K113281 | 000 |