Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006179052

FEI Number

3006179052

Entity Name

Bistos co., ltd.

City/State/Country

Yongin-si Gyeonggi, KR

Establishment Address

522, Geumeo-ro, Pogok-eup,, Cheoin-gu,, Yongin-si Gyeonggi 17030, KR

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Bistos Co., Ltd. (Owner Number: 10023402)

Owner / Operator Contact Address

7th Fl., A Bldg., Woolim Lions Valley, 5-cha, 302 Galmachi-ro, Jungwon-gu,, Seongnam, KR-41 13201, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K142332

PMA Number

N/A

All Registered Proprietary Names

Hi-dop BT-200V Fetal Doppler FM-3000 Plus BT-350 Hi bebe plus, BT-100 Duo Double Electric Breast Pump, MD-20.2 Duo Double Electric Breast Pump, AAA0021 Duo Double Electric Breast Pump, AAA0021-05 BT-300 Hi-bebe Fetal Doppler BT-200 ENCORE ENCORE PLUS BT-200T Fetal Doppler Hi-bebe BT-500 Infant Incubator NeoGenesis LT-300 HD BiliTouchTM Infant phototherapy equipment Motif Phototherapy Blanket BT-450 BT-410F BT-410A Head-worn light EYESCOPE BT-220C Prenatal Monitoring System Hi-bebe S Fetal Doppler BT-220L Prenatal Monitoring System PT-5000 NeoLight BT-400 Neonatal Phototherapy

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	Class 2	884.2740	2012-08-23
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	Class 2	884.2740	2011-05-19
HGL	Transducer, Ultrasonic, Obstetric	Obstetrics/Gynecology	Class 2	884.2960	2011-05-19
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2016-09-07
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	Class 2	884.2740	2007-11-22
HGL	Transducer, Ultrasonic, Obstetric	Obstetrics/Gynecology	Class 2	884.2960	2007-11-22
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	Class 2	884.2740	2010-06-16
FMZ	Incubator, Neonatal	General Hospital	Class 2	880.5400	2014-08-05
HEX	Colposcope (And Colpomicroscope)	Obstetrics/Gynecology	Class 2	884.1630	2025-04-30
LBI	Unit, Neonatal Phototherapy	General Hospital	Class 2	880.5700	2021-05-31
KYT	Light, Examination, Medical, Battery Powered	General Hospital	Class 1	880.6350	2021-03-21
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	Class 2	884.2740	2015-07-13
LBI	Unit, Neonatal Phototherapy	General Hospital	Class 2	880.5700	2015-03-25

Official Correspondent

No official correspondent registered.

US Agent Details

Daniel Lim Business: Bistos America Email: daniellim@bistosamericainc.com Phone: (949) 6148745

Related Public Records

Same Entity

Bistos Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K771196	Hewlett-Packard Co.	MARKER GENERATOR MODULES - 21597A	1977-08-03
K813458	Cranbury Medical Labs, Inc.	FETASCAN 1000, 1000A OBSTETRICAL DATA	1982-01-28
K100420	Philips Medizin Systeme Boeblingen GmbH	PHILIPS OBTRACEVUE MODEL SW REV. G.00	2010-07-26
K173941	Philips Medizin Systeme Boeblingen GmbH	IntelliSpace Perinatal Rev.K.00	2018-09-10
K062137	Philips Medizin Systeme Boeblingen GmbH	MODIFICATION TO PHILIPS AVALON FETAL MONITORS FM20 AND FM30	2006-08-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-06	N/A	2	FETALGARD Lite Fetal Monitors, Model AP1S (Single Fetus Monitoring)
Z-0036-06	N/A	2	FETALGARD Lite Fetal Monitors, Model HCS (Home Care Single Fetus Monitoring)
Z-0041-2020	Ohmeda Medical	2	Giraffe Omnibed - Product Usage: The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Incubators provide an enclosed, temperature-controlled environment and warmers provide infrared heat in an open environment. They may also be used for short periods of time to facilitate the neonate s transition from the uterus to the external environment. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006179052. Last updated year: 2026. Please use registration number 3006179052 when referencing this establishment in official correspondence.