TYTO CARE LTD Tyto Insights for Wheeze Detection _US Tyto Insights for Wheeze Detection
Company Name
TYTO CARE LTD
Catalog Number
Tyto Insights for Wheeze Detection _US
Description
The “Tyto Insights for Wheeze Detection” is an over-the-counter artificial intelligence (AI) enabled decision supportsoftware system used in the evaluation of lung sounds in adults and pediatrics. It automatically analyses the acousticsignal of the lung as recorded by the FDA cleared compatible Tyto Stethoscope and identifies recordings where a specificabnormal lung sound suggestive of “Wheeze” is suspected. It is not intended to detect other abnormal or normal lungsounds. A licensed health care professional’s advice is required to understand the meaning of the Tyto Insights forWheeze Detection result. Healthcare providers should consider the device result in conjunction with recording and otherrelevant patient data.
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Additional Details
Device Identifier
07290016672886
Is RX
No
Is Over the Counter
Yes
Requires Sterilization
No
Is Sterile
No
Is Single Use
No
Barcode Mapping
| Unit of Measurement | Eaches | GTIN |
|---|---|---|
| Each | 1 | 07290016672886 |