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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, monitoring, perinatal
510(k) Number K121267
Device Name BT-200V VASCULAR DOPPLER
Applicant
BISTOS CO., LTD.
111 ELLISON STREET
PATERSON,  NJ  07505
Applicant Contact YOUNG CHI
Correspondent
BISTOS CO., LTD.
111 ELLISON STREET
PATERSON,  NJ  07505
Correspondent Contact YOUNG CHI
Regulation Number884.2740
Classification Product Code
HGM  
Date Received04/26/2012
Decision Date 08/02/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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