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 the device name listed in this FDA 510(k) record. The listed applicant is Sensible Medical Innovations , Ltd.. It received FDA 510(k) clearance on 2019-02-28 under 510(k) 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. The listed applicant is Sensible Medical Innovations , Ltd.. The 510(k) number is K180479.

When did ReDS System receive FDA 510(k) clearance?

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

Who is the listed applicant for ReDS System?

The FDA 510(k) record lists Sensible Medical Innovations , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ReDS System?

The FDA product code for ReDS System is DSB.

Related Devices (Code: DSB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250634BCM2-Body Composition MonitorFresenius Medical Care Renal Therapies Group, LLC K243727Re:BalansMode Sensors AS K250922Edema Guard Monitor (EGM) CardioSet-001Cardioset Medical , Ltd.K232089SOZO ProImpediMed Limited K223217Zynex Monitoring System, Model CM-1600Zynex Medical, Inc.K211585Bodyport Cardiac ScaleBodyport, Inc.

Official Source

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