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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K212153
Device Name Biobeat Platform, BB-613WP Patch
Applicant
Biobeat Technologies , Ltd.
26 Ha'Magshimim St.
Petah Tikvah,  IL 4934835
Applicant Contact Johanan May
Correspondent
Hogan Lovells US LLP
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Correspondent Contact John J. Smith
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Codes
BZQ   DRG   DXG   DXN   FLL  
Date Received07/09/2021
Decision Date 03/25/2022
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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