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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 K142799
Device Name Model BT-220L and BT-220C
Applicant
Bistos Co., Ltd.
27 New England Drive
Ramsey,  NJ  07446
Applicant Contact Young Chi
Correspondent
Bistos Co., Ltd.
27 New England Drive
Ramsey,  NJ  07446
Correspondent Contact Young Chi
Regulation Number884.2740
Classification Product Code
HGM  
Date Received09/29/2014
Decision Date 07/09/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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