The following data is part of a premarket notification filed by Invivo Research, Inc. with the FDA for Omega 5600 Series Non-invasive Blood Pressure Monitors.
| Device ID | K945138 |
| 510k Number | K945138 |
| Device Name: | OMEGA 5600 SERIES NON-INVASIVE BLOOD PRESSURE MONITORS |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | INVIVO RESEARCH, INC. 12601 RESEARCH PKWY. Orlando, FL 32826 |
| Contact | Francis X Casey |
| Correspondent | Francis X Casey INVIVO RESEARCH, INC. 12601 RESEARCH PKWY. Orlando, FL 32826 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-20 |
| Decision Date | 1995-11-20 |