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 |