The following data is part of a premarket notification filed by Ge Medical Systems China Co., Ltd. with the FDA for Procare Monitor B20.
| Device ID | K122253 |
| 510k Number | K122253 |
| Device Name: | PROCARE MONITOR B20 |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | GE MEDICAL SYSTEMS CHINA CO., LTD. 8200 WEST TOWER AVE Milwaukee, WI 53223 |
| Contact | Robert Casarsa |
| Correspondent | Robert Casarsa GE MEDICAL SYSTEMS CHINA CO., LTD. 8200 WEST TOWER AVE Milwaukee, WI 53223 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-27 |
| Decision Date | 2013-03-22 |
| Summary: | summary |