6 devices · 4 companies · 2018 to 2026
Product code DXH: Transmitters And Receivers, Electrocardiograph, Telephone
6 devices under product code DXH, 2018 to 2026, from 4 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (5 of 6 here), the regulation, and MAUDE report counts by product code.
Transmitters And Receivers, Electrocardiograph, Telephone. 21 CFR 870.2920, Class II. MAUDE held 72 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 |
|---|---|---|---|---|
| PreemptiveAI Clinical SDKK250233 · 510(k) | Measure Labs, Inc. (Dba Preemptiveai, Inc.) | Cardiovascular | database entry | |
| Study Watch with Irregular Pulse MonitorK213357 · 510(k) | Verily Life Sciences LLC | Cardiovascular | database entry | |
| Study Watch with Irregular Pulse MonitorK192415 · 510(k) | Verily Life Sciences LLC | Cardiovascular | database entry | |
| RX-1 Rhythm Express Remote Cardiac Monitoring SyK183704 · 510(k) | VivaQuant Inc. | Cardiovascular | database entry | |
| Study WatchK182456 · 510(k) | Verily Life Sciences LLC | Cardiovascular | database entry | |
| FibriCheckK173872 · 510(k) | Qompium nv | 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.