Tyto Stethoscope (OTC)— 510(k) K181612

Substantially Equivalent

Tyto Care , Ltd.

FDA 510(k) clearance K181612 for Tyto Stethoscope (OTC), Substantially Equivalent on 2018-12-17. Applicant: Tyto Care , Ltd..

Clearance details

Applicant: Tyto Care , Ltd.
Product code: Code DQD
Advisory panel: Cardiovascular
Date received: 2018-06-19
Decision date: 2018-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Netanya, IL

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