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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 K150095
Device Name ReDs Wearable System
Applicant
Sensible Medical Innovations , Ltd.
4 Haalon St. Kefar Neter
Pob 8702
Netanya,  IL 4059300
Applicant Contact Inbal Ben-Tzvi
Correspondent
Hogan Lovells US LLP
1835 Market St.
Suite 2920
Philadelphia,  PA  19103
Correspondent Contact Janice Hogan
Regulation Number870.2770
Classification Product Code
DSB  
Date Received01/16/2015
Decision Date 08/06/2015
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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