FDA 510(k) Applications Submitted by GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K170155 |
01/18/2017 |
EK12 Algorithm |
GE Medical Systems Information Technologies, Inc. |
| K152993 |
10/13/2015 |
MUSE Cardiology Information System |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
| K220732 |
03/14/2022 |
Mural Perinatal Surveillance |
GE Medical Systems Information Technologies, Inc. |
| K222586 |
08/26/2022 |
Mural Clinical Viewer |
GE Medical Systems Information Technologies, Inc. |
| K202189 |
08/04/2020 |
Graffiti |
GE Medical Systems Information Technologies, Inc. |
| K221321 |
05/06/2022 |
MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System |
GE Medical Systems Information Technologies, Inc. |
| K230145 |
01/18/2023 |
ONE-CUF |
GE Medical Systems Information Technologies, Inc. |
| K230626 |
03/07/2023 |
PortraitÖ Central Viewer Application (Portrait CV A01), Portrait Ö Core Services (Portrait CSS01), PortraitÖ Clinical Alarming Unit (Portrait CAU01); PortraitÖ Mobile Patient Monitor (Portrait HUB01), PortraitÖ Sensor Battery (Portrait SBT01), PortraitÖ B |
GE Medical Systems Information Technologies, Inc. |
| K201941 |
07/13/2020 |
Monitor B125, Monitor B105 |
GE Medical Systems Information Technologies, Inc. |
| K213234 |
09/30/2021 |
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. |
| K213490 |
11/01/2021 |
Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P |
GE Medical Systems Information Technologies, Inc. |
| K110132 |
01/18/2011 |
MUSE CARDIOLOGY INFORMATION SYSTEM |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
| K130155 |
01/22/2013 |
MUSE CARDIOLOGY INFORMATION SYSTEM |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
| K141963 |
07/18/2014 |
12SL ECG ANALYSIS PROGRAM |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
| K132437 |
08/05/2013 |
MARS HOLTER ANALYSIS WORKSTATION |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
| K203786 |
12/28/2020 |
MAC 7 - Resting ECG Analysis System |
GE Medical Systems Information Technologies, Inc. |
| K173830 |
12/18/2017 |
MAC VU360 Resting ECG Analysis System |
GE Medical Systems Information Technologies, Inc. |
| K123996 |
12/26/2012 |
RADIAL-CUF NON-INVASIVE BLOOD PRESSURE CUFF |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
| K130626 |
03/08/2013 |
MAC-LAB HEMODYNAMIC RECORDING SYSTEM; CARDIOLAB ELECTROPHYSIOLOGY RECORDING SYSTEM; COMBOLAB HEMODYNAMIC AND ELECTROPHYS |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
| K133882 |
12/20/2013 |
CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO) |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
| K120125 |
01/17/2012 |
SOFT-CUF, CLASSIC-CUF, DURA-CUF, SENSA-CUF |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
| K221904 |
06/30/2022 |
EK12 V2 Algorithm |
GE Medical Systems Information Technologies, Inc. |
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