The following data is part of a premarket notification filed by Ge Medical Systems (china) Co., Ltd. with the FDA for Monitor B125, Monitor B105.
| Device ID | K171580 |
| 510k Number | K171580 |
| Device Name: | Monitor B125, Monitor B105 |
| 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, Inc. 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-31 |
| Decision Date | 2017-11-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682124348 | K171580 | 000 |
| 00840682124331 | K171580 | 000 |