The following data is part of a premarket notification filed by Medfusion, Inc. with the FDA for Model 3001 Syringe Infusion Pump.
Device ID | K901755 |
510k Number | K901755 |
Device Name: | MODEL 3001 SYRINGE INFUSION PUMP |
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 | 1990-04-17 |
Decision Date | 1990-08-29 |