The following data is part of a premarket notification filed by Bmeye B.v. with the FDA for Continuous Non-invasive Cardiac Output And Blood Pressure Monitor With Real-time Hemodynamics.
| Device ID | K072049 |
| 510k Number | K072049 |
| Device Name: | CONTINUOUS NON-INVASIVE CARDIAC OUTPUT AND BLOOD PRESSURE MONITOR WITH REAL-TIME HEMODYNAMICS |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | BMEYE B.V. 74 PLEASANT ST. Westford, MA 01886 |
| Contact | Jacqueline Emery |
| Correspondent | Jacqueline Emery BMEYE B.V. 74 PLEASANT ST. Westford, MA 01886 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-25 |
| Decision Date | 2007-11-29 |
| Summary: | summary |