Tyto Insights for Eardrum Bulging Detection— 510(k) DEN250014

Unknown

Tyto Care , Ltd.

FDA 510(k) clearance DEN250014 for Tyto Insights for Eardrum Bulging Detection, Unknown on 2026-03-17. Applicant: Tyto Care , Ltd.. Device class: 2.

Clearance details

Applicant: Tyto Care , Ltd.
Product code: Code SHL
Device class: Class 2
Regulation: 21 CFR 874.4775
Advisory panel: Ear, Nose, Throat
Date received: 2025-04-21
Decision date: 2026-03-17
Decision: Unknown
Clearance type: Direct
Location: Netanya, IL

View on FDA.gov ↗

More clearances from Tyto Care , Ltd.

K252844 — Tyto Insights for Wheeze Detection (with PCCP)2026-06-02
K252089 — Tyto Stethoscope (G3)2026-03-12
K243567 — Tyto Insights for Rhonchi Detection2025-04-07
K240555 — Tyto Insights for Crackles Detection2024-07-02
K232237 — Tyto Insights for Wheeze Detection2023-12-13

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