The following data is part of a premarket notification filed by Time Medical Systems Inc with the FDA for Hts Extremity Coil, Hts Surface Coil.
| Device ID | K112293 |
| 510k Number | K112293 |
| Device Name: | HTS EXTREMITY COIL, HTS SURFACE COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | TIME MEDICAL SYSTEMS INC G/F, BIO-INFORMATICS CENTRE NO.2, SCIENCE PARK WEST AVE Shatin, N.t., Hong Kong, CN Ch |
| Contact | John Baby |
| Correspondent | John Baby TIME MEDICAL SYSTEMS INC G/F, BIO-INFORMATICS CENTRE NO.2, SCIENCE PARK WEST AVE Shatin, N.t., Hong Kong, CN Ch |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-10 |
| Decision Date | 2011-09-30 |
| Summary: | summary |