The following data is part of a premarket notification filed by Mindray Ds Usa, Inc. with the FDA for V Series Monitoring System, 12.1 Dcu/v12 And 21.0 Dcu/v21.
| Device ID | K132026 |
| 510k Number | K132026 |
| Device Name: | V SERIES MONITORING SYSTEM, 12.1 DCU/V12 AND 21.0 DCU/V21 |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | MINDRAY DS USA, INC. 800 MACARTHUR BLVD Mahwah, NJ 07430 |
| Contact | Russell Olsen |
| Correspondent | Russell Olsen MINDRAY DS USA, INC. 800 MACARTHUR BLVD Mahwah, NJ 07430 |
| Product Code | MHX |
| Subsequent Product Code | CBQ |
| Subsequent Product Code | CBR |
| Subsequent Product Code | CBS |
| Subsequent Product Code | CCK |
| Subsequent Product Code | CCL |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DQK |
| Subsequent Product Code | DRT |
| Subsequent Product Code | DSI |
| Subsequent Product Code | DSK |
| Subsequent Product Code | DXG |
| Subsequent Product Code | DXN |
| Subsequent Product Code | FLL |
| Subsequent Product Code | GWM |
| Subsequent Product Code | MLD |
| Subsequent Product Code | MUD |
| Subsequent Product Code | NHO |
| Subsequent Product Code | NHP |
| Subsequent Product Code | NHQ |
| Subsequent Product Code | &nb |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-01 |
| Decision Date | 2013-12-20 |
| Summary: | summary |