Cleared Traditional

Tyto Insights for Wheeze Detection

K232237 · Tyto Care , Ltd. · Anesthesiology
Dec 2023
Decision
138d
Days
Class 2
Risk

About This 510(k) Submission

K232237 is an FDA 510(k) clearance for the Tyto Insights for Wheeze Detection, a Abnormal Breath Sound Device (Class II — Special Controls, product code PHZ), submitted by Tyto Care , Ltd. (Natanya, IL). The FDA issued a Cleared decision on December 13, 2023, 138 days after receiving the submission on July 28, 2023. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1900.

Submission Details

510(k) Number K232237 FDA.gov
FDA Decision Cleared SESE
Date Received July 28, 2023
Decision Date December 13, 2023
Days to Decision 138 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code PHZ — Abnormal Breath Sound Device
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1900
Definition The Device Is Intended To Measure Abnormal Breath Sound, Such As Wheeze, Rhonchi, And Whistling.