The following data is part of a premarket notification filed by Medic, Inc. with the FDA for Model 700ge1500 Cardiac Vascular Coil For G.e. 1.5t Signa.
| Device ID | K933295 |
| 510k Number | K933295 |
| Device Name: | MODEL 700GE1500 CARDIAC VASCULAR COIL FOR G.E. 1.5T SIGNA |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | MEDIC, INC. 925 WEST 6TH ST. P.O. BOX 737 Fremont, NE 68025 |
| Contact | Randall W Jones |
| Correspondent | Randall W Jones MEDIC, INC. 925 WEST 6TH ST. P.O. BOX 737 Fremont, NE 68025 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-07 |
| Decision Date | 1994-03-17 |