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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 K190792
Device Name BB-613WP
Applicant
Biobeat Technologies , Ltd.
26 Ha’Magshimim St.
Petah Tikvah,  IL 4934835
Applicant Contact Johanan May
Correspondent
Hogan Lovells U.S. Lpp
3 Embarcadero Center Suite 1500
San Francisco,  CA  94111
Correspondent Contact Yarmela Pavlovic
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Codes
DRG   DXN  
Date Received03/27/2019
Decision Date 08/22/2019
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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