The following data is part of a premarket notification filed by Medfusion, Inc. with the FDA for Modified Walkmed 400.
Device ID | K905783 |
510k Number | K905783 |
Device Name: | MODIFIED WALKMED 400 |
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 | 1990-12-18 |
Decision Date | 1991-01-11 |