The following data is part of a premarket notification filed by Biomedical Dynamics, Inc. with the FDA for Pressure Infusor For I.v. Bags/autoinflation.
| Device ID | K890268 |
| 510k Number | K890268 |
| Device Name: | PRESSURE INFUSOR FOR I.V. BAGS/AUTOINFLATION |
| Classification | Container, I.v. |
| Applicant | BIOMEDICAL DYNAMICS, INC. 3800 MULTIFOODS TOWER 33 SOUTH SIXTH STREET Minneapolis, MN 55402 |
| Contact | James W Moen |
| Correspondent | James W Moen BIOMEDICAL DYNAMICS, INC. 3800 MULTIFOODS TOWER 33 SOUTH SIXTH STREET Minneapolis, MN 55402 |
| Product Code | KPE |
| CFR Regulation Number | 880.5025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-18 |
| Decision Date | 1989-05-05 |