The following data is part of a premarket notification filed by Medex, Inc. with the FDA for Medfusion Model 2001 Syringe Infusion Pump.
| Device ID | K955231 |
| 510k Number | K955231 |
| Device Name: | MEDFUSION MODEL 2001 SYRINGE INFUSION PUMP |
| Classification | Pump, Infusion |
| Applicant | MEDEX, INC. 11360 TECHNOLOGY CIR. Duluth, GA 30155 |
| Contact | J H Ruffin Booth |
| Correspondent | J H Ruffin Booth MEDEX, INC. 11360 TECHNOLOGY CIR. Duluth, GA 30155 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-14 |
| Decision Date | 1996-07-18 |
| Summary: | summary |