4 devices · 1 company · 2017 to 2019
ImpediMed Limited: AI-enabled devices on FDA's list
4 devices from ImpediMed Limited, 2017 to 2019, from 1 company across 3 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (4 of 4 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from ImpediMed Limited
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| SOZOK190529 · 510(k) | Cardiovascular | QJB | database entry | |
| SOZOK180126 · 510(k) | Cardiovascular | OBH | database entry | |
| SOZOK172507 · 510(k) | Cardiovascular | DSB | database entry | |
| SOZOK172122 · 510(k) | Cardiovascular | OBH | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.