The following data is part of a premarket notification filed by Biomedical Dynamics, Inc. with the FDA for Blood Pressure Cuff.
| Device ID | K881799 |
| 510k Number | K881799 |
| Device Name: | BLOOD PRESSURE CUFF |
| Classification | Blood Pressure Cuff |
| 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 | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-27 |
| Decision Date | 1988-10-14 |