The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Unity Network Id.
| Device ID | K183116 |
| 510k Number | K183116 |
| Device Name: | Unity Network ID |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | GE Healthcare 8200 West Tower Ave. Milwaukee, WI 53223 |
| Contact | Brandon O'shea |
| Correspondent | Brandon O'shea GE Healthcare 8200 West Tower Ave. Milwaukee, WI 53223 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-09 |
| Decision Date | 2018-12-06 |
| Summary: | summary |