The following data is part of a premarket notification filed by Ge Healthcare Finland Oy with the FDA for B40i Patient Monitor.
| Device ID | K143676 |
| 510k Number | K143676 |
| Device Name: | B40i Patient Monitor |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | GE HEALTHCARE FINLAND OY KUORTANEENKATU 2 Helsinki, FI 00510 |
| Contact | Joel Kent |
| Correspondent | Joel Kent GE HEALTHCARE 86 PILGRIM ROAD Needham, MA 02492 |
| Product Code | MHX |
| Subsequent Product Code | BZQ |
| 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 | DRT |
| Subsequent Product Code | DSB |
| Subsequent Product Code | DSK |
| Subsequent Product Code | DXN |
| Subsequent Product Code | FLL |
| Subsequent Product Code | GWQ |
| Subsequent Product Code | NHO |
| Subsequent Product Code | NHP |
| Subsequent Product Code | NHQ |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-24 |
| Decision Date | 2015-07-31 |
| Summary: | summary |