MWI — Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Class II
FDA product code MWI covers "Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)", a Class II medical device regulated under 21 CFR 870.2300. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K253196 | midmark corporation | Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-30 | June 12, 2026 |
| K253436 | cosinuss | c-med0 alpha | April 30, 2026 |
| 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 |