|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
portrait vsm
|
GE Medical Systems Information Technologies, Inc.
|
K233810 |
04/25/2024
|
mural clinical viewer
|
GE Medical Systems Information Technologies, Inc.
|
K222586 |
12/21/2022
|
ek12 v2 algorithm
|
GE Medical Systems Information Technologies, Inc.
|
K221904 |
12/20/2022
|
carescape one and carescape dock f0, model numbers mbz323 and mfa101, carescape ecg, model number mke101,carescape temp, model number mkt101, carescape pres, model number mkp101, carescape spo2, model numbers mks101 and mks201
|
GE Medical Systems Information Technologies, Inc.
|
K213234 |
04/12/2022
|
monitor b105m, monitor b125m, monitor b155m, monitor b105p, monitor b125p
|
GE Medical Systems Information Technologies, Inc.
|
K213490 |
04/01/2022
|
monitor b125, monitor b105
|
GE Medical Systems Information Technologies, Inc.
|
K201941 |
11/04/2020
|
ek12 algorithm
|
GE Medical Systems Information Technologies, Inc.
|
K170155 |
06/06/2017
|
12sl ecg analysis program
|
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
|
K141963 |
02/05/2015
|
12sl ecg analysis program
|
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
|
K092369 |
02/24/2010
|
carescape monitor b850
|
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
|
K092027 |
08/28/2009
|