The following data is part of a premarket notification filed by Time Medical Limited with the FDA for Mona - Orthopedic Mri System, Model Tms-200orth-01.
| Device ID | K092230 |
| 510k Number | K092230 |
| Device Name: | MONA - ORTHOPEDIC MRI SYSTEM, MODEL TMS-200ORTH-01 |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | TIME MEDICAL LIMITED SUITE 8D,NO.19, LANE 999 ZHONGSHAN NO.2 ROAD(S) Shanghai, CN 200030 |
| Contact | Diana Hong |
| Correspondent | Marc M 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 | 2009-07-23 |
| Decision Date | 2009-11-25 |
| Summary: | summary |