ReDs Wearable System— 510(k) K150095

Substantially Equivalent

Sensible Medical Innovations , Ltd.

FDA 510(k) clearance K150095 for ReDs Wearable System, Substantially Equivalent on 2015-08-06. Applicant: Sensible Medical Innovations , Ltd..

Clearance details

Applicant: Sensible Medical Innovations , Ltd.
Product code: Code DSB
Advisory panel: Cardiovascular
Date received: 2015-01-16
Decision date: 2015-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Netanya, IL

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