The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Modification To Medrad Continuum Mr Infusion System.
| Device ID | K061128 |
| 510k Number | K061128 |
| Device Name: | MODIFICATION TO MEDRAD CONTINUUM MR INFUSION SYSTEM |
| Classification | Pump, Infusion |
| Applicant | MEDRAD, INC. ONE MEDRAD DR. Indianola, PA 15051 |
| Contact | John M Kiste |
| Correspondent | John M Kiste MEDRAD, INC. ONE MEDRAD DR. Indianola, PA 15051 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-24 |
| Decision Date | 2006-05-22 |
| Summary: | summary |