Infant Phototherapy Equipment

Unit, Neonatal Phototherapy

Bistos Co., Ltd.

The following data is part of a premarket notification filed by Bistos Co., Ltd. with the FDA for Infant Phototherapy Equipment.

Pre-market Notification Details

Device IDK210289
510k NumberK210289
Device Name:Infant Phototherapy Equipment
ClassificationUnit, Neonatal Phototherapy
Applicant Bistos Co., Ltd. 7th Fl. A Bldg., Woolim Lions Valley 5-cha, 302, Galmachi-ro, Jungwon-gu Seongnam-si,  KR 13201
ContactDae Eun Kim
CorrespondentPrithul Bom
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeLBI  
CFR Regulation Number880.5700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2021-02-02
Decision Date2021-05-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
18800012345002 K210289 000
18800012345019 K210289 000

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