| 2026-08-14 |
K260438 |
Infinium Medical, Inc.
|
Vital Signs Monitor (CLEO2) |
| 2026-08-12 |
K253417 |
Masimo Corporation
|
Masimo Root Monitoring System |
| 2026-06-12 |
K253196 |
Midmark Corporation
|
Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) |
| 2026-04-30 |
K253436 |
Cosinuss GmbH
|
c-med0 alpha |
| 2026-01-16 |
K250135 |
Baxter Healthcare Corp/ Excel Medical
|
WAVE Clinical Platform (2.0.000) |
| 2025-08-27 |
K241766 |
Fysicon BV
|
QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid) |
| 2025-06-06 |
K242737 |
Empatica S.r.l.
|
Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal |
| 2025-02-14 |
K241958 |
Ward 24/7 Aps
|
WARD-CSS (v1.2.x) |
| 2025-02-03 |
K243146 |
Ihealth Labs, Inc.
|
iCare APP |
| 2024-12-20 |
K241411 |
Welch Allyn, Inc.
|
Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) |
| 2024-12-10 |
K243216 |
Analog Devices
|
Sensinel Cardiopulmonary Management (CPM) System (ADCP1100) |
| 2024-09-27 |
K233446 |
Amc Health
|
AMC Health CareConsole |
| 2024-09-24 |
K240236 |
Happy Health, Inc.
|
Happy Ring Health Monitoring System |
| 2024-06-26 |
K233354 |
Athena Gtx, Inc.
|
WVSM Pro (Series) (500-0030-XX) |
| 2024-06-25 |
K232111 |
Laerdal Medical AS
|
NeoBeat, NeoBeat Mini |
| 2024-04-25 |
K233810 |
Ge Medical Systems Information Technologies, Inc.
|
Portrait VSM |
| 2024-04-01 |
K233133 |
Talis Clinical, LLC
|
Talis EMR with Talis +ACG (Talis EMR with +ACG) |
| 2024-03-20 |
K234130 |
Ge Medical Systems Information Technologies, Inc.
|
Portrait Mobile Monitoring Solution consists of: Portrait Central Viewer Application (Portrait CVAXB) Portrait Core Services (Portrait CSSXB) Portrait Clinical Alarming Unit (Portrait CAU01) Portrait Mobile Patient Monitor Hardware (Portrait HUBXB) Portrait Mobile Patient Monitor Software (Portrait HSWXB) Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) Portrait Wearable Pulse O |
| 2024-03-08 |
K233038 |
Edan Instruments, Inc.
|
Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s |
| 2023-12-22 |
K231086 |
Analog Devices, Inc.
|
CPM System |
| 2023-10-30 |
K230457 |
Empatica S.r.l.
|
Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal |
| 2023-09-11 |
K230881 |
Change Healthcare Israel , Ltd.
|
Change Healthcare Cardiology Hemodynamics |
| 2023-08-11 |
K230626 |
Ge Medical Systems Information Technologies, Inc.
|
Portrait Central Viewer Application (Portrait CV A01), Portrait Core Services (Portrait CSS01), Portrait Clinical Alarming Unit (Portrait CAU01); Portrait Mobile Patient Monitor (Portrait HUB01), Portrait Sensor Battery (Portrait SBT01), Portrait Bedside Charger (Portrait BCH01); Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01, Portrait SpO2 P-SP01, Portrait SpO2 P-W01 and Portrait SpO2 P-SE01); Portrait SpO2 Attachment Accessory Band (Portrait AAB01), Portrait |
| 2023-06-06 |
K220117 |
Ordinatrum Solutions
|
ARC Intensive Care Information System (ARC System) |
| 2023-06-02 |
K230214 |
Medopad, Inc.
|
Huma RPM (RPM) |