FDA 510(k) K180479, ReDS System, by Sensible Medical Innovations , Ltd.
FDA 510(k) K180479, ReDS System, by Sensible Medical Innovations , Ltd.
Device Classification Name: Plethysmograph, Impedance
510(k) Number: K180479
Device Name: ReDS System
Applicant: Sensible Medical Innovations , Ltd.
Regulation Number: 870.2770
Classification Product Code: DSB
Date Received: 02/22/2018
Decision Date: 02/28/2019
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
510k Review Panel: Cardiovascular
Total number of pages: 4,360
Fully redacted pages: 3,658
Content pages: 702
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