Cleared Traditional

Tyto Stethoscope (OTC)

K181612 · Tyto Care , Ltd. · Cardiovascular
Dec 2018
Decision
181d
Days
Class 2
Risk

About This 510(k) Submission

K181612 is an FDA 510(k) clearance for the Tyto Stethoscope (OTC), a Stethoscope, Electronic (Class II — Special Controls, product code DQD), submitted by Tyto Care , Ltd. (Netanya, IL). The FDA issued a Cleared decision on December 17, 2018, 181 days after receiving the submission on June 19, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1875.

Submission Details

510(k) Number K181612 FDA.gov
FDA Decision Cleared SESE
Date Received June 19, 2018
Decision Date December 17, 2018
Days to Decision 181 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQD — Stethoscope, Electronic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1875

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