Tyto Stethoscope— 510(k) K160401

Substantially Equivalent

Tyto Care , Ltd.

FDA 510(k) clearance K160401 for Tyto Stethoscope, Substantially Equivalent on 2016-10-19. Applicant: Tyto Care , Ltd.. Device class: 2.

Clearance details

Applicant: Tyto Care , Ltd.
Product code: Code DQD
Device class: Class 2
Regulation: 21 CFR 870.1875
Advisory panel: Cardiovascular
Date received: 2016-02-12
Decision date: 2016-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Netanya, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code DQD

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K252089 — Tyto Stethoscope (G3)2026-03-12
K252076 — Kneevoice Cartilage Evaluation System (750-3600-001)2026-02-06

More clearances from Tyto Care , Ltd.

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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.