Tyto Insights for Wheeze Detection— 510(k) K232237

Name: FDA 510(k) clearance K232237
Creator: U.S. Food and Drug Administration
Published: 2023-12-13

Substantially Equivalent

Tyto Care , Ltd.

FDA 510(k) clearance K232237 for Tyto Insights for Wheeze Detection, Substantially Equivalent on 2023-12-13. Applicant: Tyto Care , Ltd.. Device class: 2.

Clearance details

Applicant: Tyto Care , Ltd.
Product code: Code PHZ
Device class: Class 2
Regulation: 21 CFR 868.1900
Advisory panel: Anesthesiology
Date received: 2023-07-28
Decision date: 2023-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Netanya, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code PHZ

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K252844 — Tyto Insights for Wheeze Detection (with PCCP)2026-06-02
K243567 — Tyto Insights for Rhonchi Detection2025-04-07
K240555 — Tyto Insights for Crackles Detection2024-07-02
K221614 — TytoCare Lung Sounds Analyzer2023-02-24
K202062 — wheezo WheezeRate Detector2021-03-11

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K190242 — Tyto Thermometer2019-03-27
K181612 — Tyto Stethoscope (OTC)2018-12-17
K160401 — Tyto Stethoscope2016-10-19

Data sourced from openFDA. This site is unofficial and independent of the FDA.