Devices · Tyto Care Ltd.

Tyto Insights for Wheeze Detection

Tyto Care Ltd. is listed for Tyto Insights for Wheeze Detection (K232237). The FDA list gives December 13, 2023 as the date of the final decision. The lead panel is Anesthesiology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code PHZ as “Abnormal Breath Sound Device”: The device is intended to measure abnormal breath sound, such as wheeze, rhonchi, and whistling. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232237

Official FDA database record

Date of final decision

December 13, 2023

Company on the FDA list

Tyto Care Ltd.

Lead panel

Anesthesiology

Primary product code

PHZ

openFDA device name for the code

Abnormal Breath Sound Device

Device class

2

Regulation number

868.1900

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary