4 devices · 1 company · 2024 to 2025

Huxley Medical: AI-enabled devices on FDA's list

4 devices from Huxley Medical, 2024 to 2025, 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 (4 of 4 here), the regulation, and MAUDE report counts by product code.

Retrieved from FDA public records.

Every device, newest decision first

Huxley Medical · 4 devices
DecisionDevicePanelProduct codeFDA
SANSA HSATK252497 · 510(k)AnesthesiologyMNRdatabase entry
SANSA HSATK250882 · 510(k)AnesthesiologyMNRdatabase entry
SANSA HSATK244027 · 510(k)AnesthesiologyMNRdatabase entry
Huxley SANSA Home Sleep Apnea TestK240285 · 510(k)AnesthesiologyMNRdatabase entry

Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.

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Every device here is authorized for a stated use. See a record read against what it must prove, on your own file.

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