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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Electrocardiograph, Telephone
510(k) Number K170181
Device Name Prizma
Applicant
G-Medical Innovations , Ltd.
5 Openheimer St., Park Rabin
Rehovot,  IL 7670105
Applicant Contact N. Epstein
Correspondent
Hogan Lovells US LLP
Columbia Sq.
555 Thirteenth St., NW
Washington, D.C.,  DC  20004
Correspondent Contact Jonathan Kahan
Regulation Number870.2920
Classification Product Code
DXH  
Subsequent Product Codes
DQA   FLL  
Date Received01/19/2017
Decision Date 09/01/2017
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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