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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 K181006
Device Name BB-613 Watch Oximeter
Applicant
Bio-Beat Technologies , Ltd.
26 Magshimim St.
Petach Tikvah,  IL 4934835
Applicant Contact Johanan May
Correspondent
Hogan Lovells US LLP
3 Embarcadero Center Suite 1500
San Francisco,  CA  94111
Correspondent Contact Yarmela Pavlovic
Regulation Number870.2700
Classification Product Code
DQA  
Date Received04/16/2018
Decision Date 09/21/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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