The following data is part of a premarket notification filed by Medic, Inc. with the FDA for Model #801ge1500 Pediatric Array Coil.
| Device ID | K951649 |
| 510k Number | K951649 |
| Device Name: | MODEL #801GE1500 PEDIATRIC ARRAY COIL |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | MEDIC, INC. P.O. BOX 737 925 WEST 6TH STREET Fremont, NE 68025 |
| Contact | Randall W Jones |
| Correspondent | Randall W Jones MEDIC, INC. P.O. BOX 737 925 WEST 6TH STREET 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 | 1995-04-10 |
| Decision Date | 1995-06-22 |