The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies, Inc. with the FDA for Monitor B125, Monitor B105.
| Device ID | K201941 |
| 510k Number | K201941 |
| Device Name: | Monitor B125, Monitor B105 |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | GE Medical Systems Information Technologies, Inc. 8200 West Tower Avenue Milwaukee, WI 53223 |
| Contact | Joel Kent |
| Correspondent | Joel Kent 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 | DPZ |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DQK |
| Subsequent Product Code | DRT |
| Subsequent Product Code | DSI |
| Subsequent Product Code | DSJ |
| Subsequent Product Code | DSK |
| Subsequent Product Code | DXN |
| Subsequent Product Code | FLL |
| Subsequent Product Code | GWQ |
| Subsequent Product Code | KRB |
| Subsequent Product Code | MLD |
| Subsequent Product Code | NHO |
| Subsequent Product Code | &nb |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-13 |
| Decision Date | 2020-11-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682140935 | K201941 | 000 |
| 00840682141291 | K201941 | 000 |
| 00840682138581 | K201941 | 000 |
| 00840682138574 | K201941 | 000 |