2 devices · 2 companies · 2020 to 2026
Product code DSI: Detector And Alarm, Arrhythmia
2 devices under product code DSI, 2020 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 2 here), the regulation, and MAUDE report counts by product code.
Detector And Alarm, Arrhythmia. 21 CFR 870.1025, Class II. MAUDE held 33,431 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.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| BodyGuardian Remote Monitoring SystemK243349 · 510(k) | Boston Scientific Cardiac Diagnostic Technologies, Inc. | Cardiovascular | database entry | |
| BodyGuardian Remote Monitoring SystemK192732 · 510(k) | Preventice Technologies, Inc. | 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.