The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Medrad Continuum Mr Compatible Infusion System.
| Device ID | K021988 |
| 510k Number | K021988 |
| Device Name: | MEDRAD CONTINUUM MR COMPATIBLE INFUSION SYSTEM |
| Classification | Pump, Infusion |
| Applicant | MEDRAD, INC. ONE MEDRAD DR. Indianola, PA 15051 |
| Contact | Lorraine R Fredes |
| Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2002-06-18 |
| Decision Date | 2002-08-29 |