The following data is part of a premarket notification filed by Lidco Ltd with the FDA for Lidcounity V2 Hemodynamic Monitor.
| Device ID | K163334 |
| 510k Number | K163334 |
| Device Name: | LiDCOunity V2 Hemodynamic Monitor |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | LiDCO Ltd 16 ORSMAN ROAD London, GB N1 5qj |
| Contact | Ji Hee Ko |
| Correspondent | Ji Hee Ko LiDCO Ltd 16 ORSMAN ROAD London, GB N1 5qj |
| Product Code | DXG |
| Subsequent Product Code | DXN |
| Subsequent Product Code | GWQ |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-28 |
| Decision Date | 2017-06-05 |