The following data is part of a premarket notification filed by Ge Hangwei Medical Systems Co., Ltd. with the FDA for Ge 8ch Foot Ankle Coil.
| Device ID | K122694 |
| 510k Number | K122694 |
| Device Name: | GE 8CH FOOT ANKLE COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | GE HANGWEI MEDICAL SYSTEMS CO., LTD. 3200 N GRANDVIEW BLVD MAIL CODE-W-827 Waukesha, WI 53188 |
| Contact | Glen Sabin |
| Correspondent | Glen Sabin GE HANGWEI MEDICAL SYSTEMS CO., LTD. 3200 N GRANDVIEW BLVD MAIL CODE-W-827 Waukesha, WI 53188 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-04 |
| Decision Date | 2012-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682119214 | K122694 | 000 |