5 devices · 4 companies · 2018 to 2025
Product code MWI: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
5 devices under product code MWI, 2018 to 2025, from 4 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (5 of 5 here), the regulation, and MAUDE report counts by product code.
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms). 21 CFR 870.2300, Class II. MAUDE held 2,174 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Empatica Health Monitoring PlatformK242737 · 510(k) | Empatica S.R.L. | Cardiovascular | database entry | |
| Eko Analysis SoftwareK192004 · 510(k) | Eko Devices Inc | Cardiovascular | database entry | |
| PeraMobile and PeraWatchK183370 · 510(k) | PeraHealth, Inc. | Cardiovascular | database entry | |
| PeraServer and PeraTrendK172959 · 510(k) | PeraHealth, Inc. | Cardiovascular | database entry | |
| WAVE Clinical PlatformK171056 · 510(k) | Excel Medical Electronics, LLC | Cardiovascular | database entry |
Every product code in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.