MWI — Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Class II
FDA Device Classification
Classification Details
- Product Code
- MWI
- Device Class
- Class II
- Regulation Number
- 870.2300
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K250135 | baxter healthcare corp/ excel medical | WAVE Clinical Platform (2.0.000) | January 16, 2026 |
| K241766 | fysicon | QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid) | August 27, 2025 |
| K242737 | empatica | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | June 6, 2025 |
| K241958 | ward 24/7 aps | WARD-CSS (v1.2.x) | February 14, 2025 |
| K243146 | ihealth labs | iCare APP | February 3, 2025 |
| K241411 | welch allyn | Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) | December 20, 2024 |
| K243216 | analog devices | Sensinel Cardiopulmonary Management (CPM) System (ADCP1100) | December 10, 2024 |
| K233446 | amc health | AMC Health CareConsole | September 27, 2024 |
| K240236 | happy health | Happy Ring Health Monitoring System | September 24, 2024 |
| K233354 | athena gtx | WVSM Pro (Series) (500-0030-XX) | June 26, 2024 |
| K232111 | laerdal medical | NeoBeat, NeoBeat Mini | June 25, 2024 |
| K233810 | ge medical systems information technologies | Portrait VSM | April 25, 2024 |
| K233133 | talis clinical | Talis EMR with Talis +ACG (Talis EMR with +ACG) | April 1, 2024 |
| K234130 | ge medical systems information technologies | Portrait Mobile Monitoring Solution consists of: Portrait Central Viewer A | March 20, 2024 |
| K233038 | edan instruments | Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s | March 8, 2024 |
| K231086 | analog devices | CPM System | December 22, 2023 |
| K230457 | empatica | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | October 30, 2023 |
| K230881 | change healthcare israel | Change Healthcare Cardiology Hemodynamics | September 11, 2023 |
| K230626 | ge medical systems information technologies | Portrait Central Viewer Application (Portrait CV A01), Portrait Core Services | August 11, 2023 |
| K220117 | ordinatrum solutions | ARC Intensive Care Information System (ARC System) | June 6, 2023 |