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 0100140201, Pediatric Head-spine Coil.
| Device ID | K081322 |
| 510k Number | K081322 |
| Device Name: | MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL 0100140201, PEDIATRIC HEAD-SPINE COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD 340 SHADY GROVE ROAD Flintville, TN 37335 |
| Contact | Charles Mack |
| 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 | 2008-05-12 |
| Decision Date | 2008-06-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970564410666 | K081322 | 000 |
| 06970564410062 | K081322 | 000 |