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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 K222010
Device Name Biobeat Platform-2 and BB-613WP Patch
Applicant
BioBeat Technologies Ltd.
26 Ha'magshimim Street
Petah Tikvah,  IL 4934835
Applicant Contact Johanan May
Correspondent
Hogan Lovells U.S. LLP
555 Thirteenth Street NW
Washington,  DC  20004
Correspondent Contact John J Smith
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Codes
BZQ   DRG   DXG   DXN   FLL  
Date Received07/07/2022
Decision Date 12/30/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT04955184
Reviewed by Third Party No
Combination Product No
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