The following data is part of a premarket notification filed by Ivy Biomedical Systems, Inc. with the FDA for Model 404 Adult Heart Rate/blood Pressure Monitor.
| Device ID | K882188 |
| 510k Number | K882188 |
| Device Name: | MODEL 404 ADULT HEART RATE/BLOOD PRESSURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | IVY BIOMEDICAL SYSTEMS, INC. 11 BUSINESS PARK DR. Branford, CT 06405 |
| Contact | Brenda E Lundy |
| Correspondent | Brenda E Lundy IVY BIOMEDICAL SYSTEMS, INC. 11 BUSINESS PARK DR. Branford, CT 06405 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-24 |
| Decision Date | 1988-07-28 |