The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Ohmeda 2350 Finapres(r) Blood Pressure Monitor.
| Device ID | K880572 |
| 510k Number | K880572 |
| Device Name: | OHMEDA 2350 FINAPRES(R) BLOOD PRESSURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | OHMEDA MEDICAL 355 INVERNESS DR.SOUTH Englewood, CO 80112 -5810 |
| Contact | Deana D Dickerson |
| Correspondent | Deana D Dickerson OHMEDA MEDICAL 355 INVERNESS DR.SOUTH Englewood, CO 80112 -5810 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-11 |
| Decision Date | 1988-05-10 |