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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 Street
petah tikvah,  IL 4934835
Applicant Contact johanan may
Correspondent
Hogan Lovells US 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
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