The following data is part of a premarket notification filed by Biomedical Dynamics, Inc. with the FDA for Infusable.
Device ID | K911216 |
510k Number | K911216 |
Device Name: | INFUSABLE |
Classification | Infusor, Pressure, For I.v. Bags |
Applicant | BIOMEDICAL DYNAMICS, INC. 12250 NICOLLET AVE. Burnsville, MN 55337 |
Contact | Matthew Bellin |
Correspondent | Matthew Bellin BIOMEDICAL DYNAMICS, INC. 12250 NICOLLET AVE. Burnsville, MN 55337 |
Product Code | KZD |
CFR Regulation Number | 880.5420 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-03-19 |
Decision Date | 1991-07-22 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
INFUSABLE 73634601 1446228 Live/Registered |
BIOMEDICAL DYNAMICS CORPORATION 1986-12-10 |