TytoCare Lung Sounds Analyzer— 510(k) K221614

Substantially Equivalent

Tyto Care , Ltd.

FDA 510(k) clearance K221614 for TytoCare Lung Sounds Analyzer, Substantially Equivalent on 2023-02-24. 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: 2022-06-03
Decision date: 2023-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Netanya, IL

Download summary PDF View on FDA.gov ↗

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