The following data is part of a premarket notification filed by Medex, Inc. with the FDA for Medex 3000 Series Mri Compatible Syringe Infusion Pump.
| Device ID | K000328 |
| 510k Number | K000328 |
| Device Name: | MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP |
| Classification | Pump, Infusion |
| Applicant | MEDEX, INC. 6250 SHIER RINGS RD. Dublin, OH 40316 |
| Contact | Cathy Chenetski |
| Correspondent | Cathy Chenetski MEDEX, INC. 6250 SHIER RINGS RD. Dublin, OH 40316 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-02 |
| Decision Date | 2000-05-09 |