The following data is part of a premarket notification filed by Shanghai Chenguang Medical Technologies Co, Ltd with the FDA for Magnetic Resonance Diagnostic Device, Model Cg-kfc18-h150-ap - Knee/foot/ankle Coil.
| Device ID | K071847 |
| 510k Number | K071847 |
| Device Name: | MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL CG-KFC18-H150-AP - KNEE/FOOT/ANKLE COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD 6A, BUILDING-2, NO. 398 TIANLIN RD Shanghai, CN 200233 |
| Contact | Songtao Zhang |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-07-05 |
| Decision Date | 2007-07-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970564410024 | K071847 | 000 |