The following data is part of a premarket notification filed by General Electric Co. with the FDA for Ge Shoulder Surface Coil, Cat. #m1085an.
| Device ID | K892235 |
| 510k Number | K892235 |
| Device Name: | GE SHOULDER SURFACE COIL, CAT. #M1085AN |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
| Contact | Kroger, Phd |
| Correspondent | Kroger, Phd GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-04 |
| Decision Date | 1989-05-11 |