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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plethysmograph, Impedance
510(k) Number K180479
Device Name ReDS System
Applicant
Sensible Medical Innovations , Ltd.
6 Meir Areil St.
Netanya, Pob 8702,  IL 4059300
Applicant Contact Inbal Ben-Tzvi
Correspondent
Hogan Lovells US LLP
1735 Market St.
Floor 23
Philadelphia,  PA  19103
Correspondent Contact Janice Hogan
Regulation Number870.2770
Classification Product Code
DSB  
Date Received02/22/2018
Decision Date 02/28/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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