The following data is part of a premarket notification filed by General Electric Co. with the FDA for Ge Brainwave Option(s) For Mri Systems.
| Device ID | K033867 |
| 510k Number | K033867 |
| Device Name: | GE BRAINWAVE OPTION(S) FOR MRI SYSTEMS |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
| Contact | Larry A Kroger |
| Correspondent | Larry A Kroger GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-12 |
| Decision Date | 2003-12-19 |
| Summary: | summary |