The following data is part of a premarket notification filed by Shanghai Chenguang Medical Technologies Co, Ltd with the FDA for Pediatric Head-spine Coil (model:5000012701.
| Device ID | K101858 |
| 510k Number | K101858 |
| Device Name: | PEDIATRIC HEAD-SPINE COIL (MODEL:5000012701 |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD BLDG 8, LANE 1199, JIDI ROAD Shanghai, CN 201107 |
| Contact | Jie Huang |
| Correspondent | Marc M Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-07-02 |
| Decision Date | 2010-07-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970564410673 | K101858 | 000 |
| 06970564410192 | K101858 | 000 |