2 devices · 1 company · 2017 to 2018

Zephyr Sleep Technologies: AI-enabled devices on FDA's list

2 devices from Zephyr Sleep Technologies, 2017 to 2018, from 1 company across 2 product codes. 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.

Retrieved from FDA public records.

Product codes from Zephyr Sleep Technologies

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Zephyr Sleep Technologies · 2 devices
DecisionDevicePanelProduct codeFDA
MATRx plusDEN170090 · De NovoDentalQCJdatabase entry
MATRx plusK163665 · 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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