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FDA 510(k)

ReDS System

K-Number: K180479 · 2019-02-28

ApplicantSensible Medical Innovations , Ltd.
Decision Date2019-02-28
Product CodeDSB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ReDS System is a medical device manufactured by Sensible Medical Innovations , Ltd.. It received FDA 510(k) clearance on 2019-02-28 under approval number K180479. The device is classified under product code DSB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ReDS System?

ReDS System is a medical device that received FDA 510(k) clearance on 2019-02-28. It is manufactured by Sensible Medical Innovations , Ltd.. The 510(k) number is K180479.

When was ReDS System approved by the FDA?

ReDS System received FDA 510(k) clearance on 2019-02-28, under approval number K180479.

What company makes ReDS System?

ReDS System is manufactured by Sensible Medical Innovations , Ltd..

What is the FDA product code for ReDS System?

The FDA product code for ReDS System is DSB.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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