|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
case v7.0 cardiac testing system and cardiosoft v7.0 cardiac testing system
|
GE Medical Systems Information Technologies, Inc.
|
K231870 |
12/13/2023
|
mac 5 a4/ mac 5 a5/ mac 5 lite resting ecg analysis system
|
GE Medical Systems Information Technologies, Inc.
|
K221321 |
10/18/2022
|
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
|
mac 7 - resting ecg analysis system
|
GE Medical Systems Information Technologies, Inc.
|
K203786 |
04/30/2021
|
graffiti
|
GE Medical Systems Information Technologies, Inc.
|
K202189 |
12/08/2020
|
monitor b125, monitor b105
|
GE Medical Systems Information Technologies, Inc.
|
K201941 |
11/04/2020
|
mac vu360 resting ecg analysis system
|
GE Medical Systems Information Technologies, Inc.
|
K173830 |
09/18/2018
|
muse cardiology information system
|
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
|
K152993 |
01/12/2016
|
mars holter analysis workstation
|
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
|
K132437 |
12/04/2013
|