Cleared Traditional

K160401 - Tyto Stethoscope
(FDA 510(k) Clearance)

K160401 · Tyto Care , Ltd. · Cardiovascular

Oct 2016

Decision

250d

Days

Class 2

Risk

K160401 is an FDA 510(k) clearance for the Tyto Stethoscope, a Stethoscope, Electronic (Class II — Special Controls, product code DQD), submitted by Tyto Care , Ltd. (Netanya, IL). The FDA issued a Cleared decision on October 19, 2016, 250 days after receiving the submission on February 12, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1875.

Submission Details

510(k) Number	K160401 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 12, 2016
Decision Date	October 19, 2016
Days to Decision	250 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF