The following data is part of a premarket notification filed by National Custom Ent., Inc. with the FDA for Medfusion 2001 & 2010, Model N7215iwc.
| Device ID | K012259 |
| 510k Number | K012259 |
| Device Name: | MEDFUSION 2001 & 2010, MODEL N7215IWC |
| Classification | Accessories, Pump, Infusion |
| Applicant | NATIONAL CUSTOM ENT., INC. 1133 EAST CLIFF RD. Burnsville, MN 55337 |
| Contact | Don Pelletier |
| Correspondent | Don Pelletier NATIONAL CUSTOM ENT., INC. 1133 EAST CLIFF RD. Burnsville, MN 55337 |
| Product Code | MRZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-18 |
| Decision Date | 2001-09-12 |