3 devices · 1 company · 2023 to 2024
Beacon Biosignals, Inc.: AI-enabled devices on FDA's list
3 devices from Beacon Biosignals, Inc., 2023 to 2024, from 1 company across 1 product code. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (3 of 3 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| Dreem 3SK242094 · 510(k) | Neurology | OLZ | database entry | |
| SleepStageMLK233438 · 510(k) | Neurology | OLZ | database entry | |
| Dreem 3SK223539 · 510(k) | Neurology | OLZ | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.