ReDS System— 510(k) K180479

Name: FDA 510(k) clearance K180479
Creator: U.S. Food and Drug Administration
Published: 2019-02-28

Substantially Equivalent

Sensible Medical Innovations , Ltd.

FDA 510(k) clearance K180479 for ReDS System, Substantially Equivalent on 2019-02-28. Applicant: Sensible Medical Innovations , Ltd.. Device class: 2.

Clearance details

Applicant: Sensible Medical Innovations , Ltd.
Product code: Code DSB
Device class: Class 2
Regulation: 21 CFR 870.2770
Advisory panel: Cardiovascular
Date received: 2018-02-22
Decision date: 2019-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Netanya, Pob 8702, IL

Download summary PDF View on FDA.gov ↗

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