The following data is part of a premarket notification filed by Shanghai Chenguang Medical Technologies Co, Ltd with the FDA for Carotid Coil.
| Device ID | K112002 |
| 510k Number | K112002 |
| Device Name: | CAROTID COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD BLDG 8, LANE 1199, JIDI ROAD Shanghai, CN 201107 |
| Contact | Meijuan Chen |
| Correspondent | Meijuan Chen SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD BLDG 8, LANE 1199, JIDI ROAD Shanghai, CN 201107 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-13 |
| Decision Date | 2011-11-18 |
| Summary: | summary |