The following data is part of a premarket notification filed by Biomedical Dynamics, Inc. with the FDA for Cuffable.
| Device ID | K911213 |
| 510k Number | K911213 |
| Device Name: | CUFFABLE |
| Classification | Blood Pressure Cuff |
| 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 | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-19 |
| Decision Date | 1991-08-07 |