The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Ge Signa Profile 6 Inch Gp Coil.
| Device ID | K041921 |
| 510k Number | K041921 |
| Device Name: | GE SIGNA PROFILE 6 INCH GP COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | GE MEDICAL SYSTEMS, LLC PO BOX 414 W-400 Milwaukee, WI 53201 |
| Contact | Larry A Kroger |
| Correspondent | Larry A Kroger GE MEDICAL SYSTEMS, LLC PO BOX 414 W-400 Milwaukee, WI 53201 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-16 |
| Decision Date | 2004-07-26 |
| Summary: | summary |