BT-350

System, Monitoring, Perinatal

BISTOS CO., LTD.

The following data is part of a premarket notification filed by Bistos Co., Ltd. with the FDA for Bt-350.

Pre-market Notification Details

Device IDK103545
510k NumberK103545
Device Name:BT-350
ClassificationSystem, Monitoring, Perinatal
Applicant BISTOS CO., LTD. 4802 GLENWOOD ROAD Brooklyn,  NY  11234
ContactSteve Kohn
CorrespondentSteve Kohn
BISTOS CO., LTD. 4802 GLENWOOD ROAD Brooklyn,  NY  11234
Product CodeHGM  
CFR Regulation Number884.2740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-12-02
Decision Date2011-05-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10887529000066 K103545 000
10887529000059 K103545 000

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