The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Medrad Continuum Mr Infusion System With Wireless Remote Accessory.
| Device ID | K073051 |
| 510k Number | K073051 |
| Device Name: | MEDRAD CONTINUUM MR INFUSION SYSTEM WITH WIRELESS REMOTE ACCESSORY |
| Classification | Pump, Infusion |
| Applicant | MEDRAD, INC. ONE MEDRAD DR. Indianola, PA 15051 |
| Contact | Leslie S O'nan |
| Correspondent | Leslie S O'nan MEDRAD, INC. ONE MEDRAD DR. Indianola, PA 15051 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-29 |
| Decision Date | 2008-05-30 |
| Summary: | summary |