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510(k) K180479

ReDS System by Sensible Medical Innovations , Ltd. — Product Code DSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 2019
Date Received
February 22, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plethysmograph, Impedance
Device Class
Class II
Regulation Number
870.2770
Review Panel
CV
Submission Type

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