Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015616170

FEI Number

3015616170

Entity Name

SHENZHEN SINO-K MEDICAL TECHNOLOGY CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

4th Floor, Building 2, West Side of Xixiang Veterans Industry City, Gongle Community, Xixiang Street, Baoan District, Shenzhen Guangdong 518101, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shenzhen SINO-K Medical Technology Co., Ltd. (Owner Number: 10084033)

Owner / Operator Contact Address

4th Floor, Building 2, West Side of Xixiang Veterans Industry City, Gongle Community, Xixiang Street, Baoan District, Shenzhen, CN-GD 518101, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K223807

PMA Number

N/A

All Registered Proprietary Names

ECG/EKG cable and lead-wires (model: SG31XXS, SG31XXP, SG51XXS, SG51XXP) ECG/EKG cable and lead-wires (model: SK11XXB, SK12XXB, SK11XXN, SK12XXN) ECG/EKG cable and lead-wires (model: SG32XXS, SG32XXP, SG52XXS, SG52XXP) Disposable SpO2 Sensor (model: SP1319, SP1319A, SP1219, SP1219A, SP1019, SP1019A, SP1002, SP1003, SP1015A) Disposable SpO2 Sensor (model: SP1119, SP1119A) Disposable NIBP Cuff: SC0101, SC0102, SC0103, SC0104, SC0105, SC0106, SC0107, SC0108, SC0109, SC0110, SC0111, SC0112 Reusable NIBP Cuff: SC1311, SC1511, SC1611, SC1711, SC1811 Disposable Temperature Probe (model: ST5105A, ST6105A) Reusable Temperature Probe (model: ST1304, ST2304, ST3304, ST4304)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2022-01-11
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2022-01-11
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2023-09-03
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2023-08-30

Official Correspondent

No official correspondent registered.

US Agent Details

Linda Chen Business: Dynasty Medical Consulting Inc. Email: usagent@chonconn.com Phone: (832) 3809688

Related Public Records

Same Entity

Shenzhen SINO-K Medical 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
3017528618	ATRILITY MEDICAL, INC.	Madison, WI, US
3003584029	Braemar Manufacturing, LLC	San Diego, CA, US
3030387292	WISE S.p.A.	Cologno Monzese Lombardy, IT
3033919280	DONGGUAN GOOCHAIN TECHNOLOGY CO., LTD	Dongguan Guangdong, CN
3017619000	SHENZHEN REDY-MED TECHNOLOGY CO., LTD.	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015616170. Last updated year: 2026. Please use registration number 3015616170 when referencing this establishment in official correspondence.