The following data is part of a premarket notification filed by Medic, Inc. with the FDA for 1.5t Scanmed Pv Array.
| Device ID | K022395 |
| 510k Number | K022395 |
| Device Name: | 1.5T SCANMED PV ARRAY |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | MEDIC, INC. 6912 NORTH 97TH CIRCLE, SUITE C Omaha, NE 68122 |
| Contact | Randall W Jones |
| Correspondent | Randall W Jones MEDIC, INC. 6912 NORTH 97TH CIRCLE, SUITE C Omaha, NE 68122 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-23 |
| Decision Date | 2002-08-13 |
| Summary: | summary |