Model BT-220L And BT-220C

System, Monitoring, Perinatal

Bistos Co., Ltd.

The following data is part of a premarket notification filed by Bistos Co., Ltd. with the FDA for Model Bt-220l And Bt-220c.

Pre-market Notification Details

Device IDK142799
510k NumberK142799
Device Name:Model BT-220L And BT-220C
ClassificationSystem, Monitoring, Perinatal
Applicant Bistos Co., Ltd. 27 New England Drive Ramsey,  NJ  07446
ContactYoung Chi
CorrespondentYoung Chi
Bistos Co., Ltd. 27 New England Drive Ramsey,  NJ  07446
Product CodeHGM  
CFR Regulation Number884.2740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-29
Decision Date2015-07-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30887529000091 K142799 000
30887529000084 K142799 000

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