The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Unity Network Id.
Device ID | K170199 |
510k Number | K170199 |
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 | Robert Casarsa |
Correspondent | Robert Casarsa 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 | 2017-01-23 |
Decision Date | 2017-05-12 |
Summary: | summary |