The following data is part of a premarket notification filed by Shenzhen Comen Medical Instruments Co.,ltd. with the FDA for C50 And C80 Multi-parameter Patient Monitor.
| Device ID | K191106 |
| 510k Number | K191106 |
| Device Name: | C50 And C80 Multi-parameter Patient Monitor |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | Shenzhen Comen Medical Instruments Co.,Ltd. Floor 11 And Section C Of Floor 12 Of Building 1A & Floor 1 To Floor 5 Of Building 2, FIYTA Timepiece Bldg, Nanhuan Ave. Shenzhen, CN 518106 |
| Contact | Hongbo Yan |
| Correspondent | Hongbo Yan Shenzhen Comen Medical Instruments Co.,Ltd. Floor 11 And Section C Of Floor 12 Of Building 1A & Floor 1 To Floor 5 Of Building 2, FIYTA Timepiece Bldg, Nanhuan Ave. Shenzhen, CN 518106 |
| 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 | DPS |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DRT |
| Subsequent Product Code | DSB |
| Subsequent Product Code | DSI |
| Subsequent Product Code | DSJ |
| Subsequent Product Code | DSK |
| Subsequent Product Code | DXG |
| Subsequent Product Code | DXN |
| Subsequent Product Code | FLL |
| Subsequent Product Code | GXY |
| Subsequent Product Code | MLD |
| Subsequent Product Code | NHO |
| Subsequent Product Code | NHP |
| Subsequent Product Code | &nb |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-25 |
| Decision Date | 2019-12-13 |