The following data is part of a premarket notification filed by Biomedical Dynamics, Inc. with the FDA for Biomedical Dynamics Disposable Pressure Infusor.
| Device ID | K861977 |
| 510k Number | K861977 |
| Device Name: | BIOMEDICAL DYNAMICS DISPOSABLE PRESSURE INFUSOR |
| Classification | Infusor, Pressure, For I.v. Bags |
| 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 | KZD |
| CFR Regulation Number | 880.5420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-21 |
| Decision Date | 1986-07-15 |