3 devices · 2 companies · 2008 to 2026
Product code MHX: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
3 devices under product code MHX, 2008 to 2026, from 2 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (2 of 3 here), the regulation, and MAUDE report counts by product code.
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms). 21 CFR 870.1025, Class II. MAUDE held 33,126 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 |
|---|---|---|---|---|
| Corvair MonzaK252589 · 510(k) | AliveCor, Inc. | Cardiovascular | database entry | |
| CorvairK231010 · 510(k) | AliveCor, Inc. | Cardiovascular | database entry | |
| VISENSIAK081140 · 510(k) | OBS MEDICAL | 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.