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 |