Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016859940

FEI Number

3016859940

Entity Name

JIANGSU KONSUNG BIO-MEDICAL SCIENCE AND TECHNOLOGY CO LTD

City/State/Country

Danyang Jiangsu, CN

Establishment Address

No.8,Shengchang West Road, Danyang Development Zone,, Danyang Jiangsu 212300, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Jiangsu Konsung Bio-Medical Science And Technology Co.,Ltd. (Owner Number: 10066875)

Owner / Operator Contact Address

NO.8, Shengchang West Road, Danyang Development Zone, Danyang, CN-JS 212300, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K223740

PMA Number

N/A

All Registered Proprietary Names

Fingertip Pulse Oximeter( SONOSAT-K01P, SONOSAT-K02P,SONOSAT-K01LP, SONOSAT-K02LP) Fingertip Pulse Oximeter (SONOSAT-K01SW,SONOSAT-K02SW,SONOSAT-K01T, SONOSAT-K02T,SONOSAT-K01LT, SONOSAT-K02LT) Fingertip Pulse Oximeter (SONOSAT-K01R, SONOSAT-K02R,SONOSAT-K01SR, SONOSAT-K02SR,SONOSAT-K01W, SONOSAT-K02W) Wrist Pulse Oximeter model SONOSAT-W01T Uric acid test card (dry chemical method) DiaCard-11 Fingertip Pulse Oximeter models SONOSAT-F01T, SONOSAT-F02T oxygen concentrator (Model: KSW-5, KSN-5, KSOC-5)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OCH	Oximeter, Infrared, Sporting, Aviation	Cardiovascular	Class 2	870.2700	2021-08-06
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2020-04-05
KNK	Acid, Uric, Uricase (Colorimetric)	Clinical Chemistry	Class 1	862.1775	2025-12-02
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2020-04-05
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2023-10-12

Official Correspondent

Baohong Li

US Agent Details

Mateo Carrasco Business: Carrasco Email: mateo@afpharmaservice.com Phone: (407) 2849480

Related Public Records

Same Entity

Jiangsu Konsung Bio-Medical Science And Technology 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
K903523	Hewlett-Packard Co.	HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE	1990-10-23
K973147	Nellcor Puritan Bennett, Inc.	NPB-295 PULSE OXIMETER	1997-11-14
K231243	Guangdong Genial Technology Co., Ltd.	Finger Clip Pulse Oximeter	2023-10-31
K971628	Somanetics Corp.	SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)	1997-10-10
K153184	Shenzhen Caremed Medical Technology Co., Ltd.	Caremed Reusable & Disposable SPO2 Sensors	2017-01-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M, Part Number CS08653
Z-0029-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M W/PRINTER, Part Number CS08659

Similar Registrations

Registration Number	Establishment Name	Location
3016170326	ZHUHAI LINTE MEDICAL INSTRUMENT CO., LTD.	Zhuhai Guangdong, CN
3008830133	SHENZHEN AEON TECHNOLOGY CO.,LTD	shenzhen Guangdong, CN
3013545943	Prime Med Shop LLC	Stafford, TX, US
3009327812	Proactive Medical Products	Mount Vernon, NY, US
3017207990	SHENZHEN YUEZHONGXING TECHNOLOGY CO.,LTD	Huizhou Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016859940. Last updated year: 2026. Please use registration number 3016859940 when referencing this establishment in official correspondence.