The following data is part of a premarket notification filed by Medfusion, Inc. with the FDA for Model 2001, Modification.
| Device ID | K905029 |
| 510k Number | K905029 |
| Device Name: | MODEL 2001, MODIFICATION |
| Classification | Pump, Infusion |
| Applicant | MEDFUSION, INC. 3450 RIVER GREEN COURT Duluth, GA 30136 |
| Contact | Ruffin Booth |
| Correspondent | Ruffin Booth MEDFUSION, INC. 3450 RIVER GREEN COURT Duluth, GA 30136 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-31 |
| Decision Date | 1990-12-24 |