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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
G-Medical Innovations Ltd.
5 Openheimer St., Park Rabin
rehovot,  IL 7670105
Applicant Contact n. epstein
Hogan Lovells US LLP
Columbia Square, 555 Thirteenth Street, NW
washington,  DC  20004
Correspondent Contact jonathan kahan
Regulation Number870.2920
Classification Product Code
Subsequent Product Codes
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