The following data is part of a premarket notification filed by Ge Medical Systems China Co., Ltd. with the FDA for Monitor B40.
| Device ID | K151063 |
| 510k Number | K151063 |
| Device Name: | Monitor B40 |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | GE MEDICAL SYSTEMS CHINA CO., LTD. NO. 19 CHANGJIANG ROAD, NATIONAL HI-TECH DEV. ZONE Wuxi, CN 214028 |
| Contact | Sun Yanli |
| Correspondent | Robert Casarsa GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVENUE Milwaukee, WI 53223 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-20 |
| Decision Date | 2015-12-15 |
| Summary: | summary |