Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013426279

FEI Number

3013426279

Entity Name

MED-LINKET CORP

City/State/Country

Alhambra, CA, US

Establishment Address

245 East Main Street, Suite 115, Alhambra, CA 91801, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MED-LINKET CORP (Owner Number: 10054780)

Owner / Operator Contact Address

245 East Main Street, Suite 115, Alhambra, CA 91801, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K160530

PMA Number

N/A

All Registered Proprietary Names

Med-linket Oximeter disposable sensor MED-LINKET Disposable Spo2 Sensor S0005J-S S0005K-S S0005L-L S0005M-L S0005N-L Med-linket disposable Spo2 sensor Pulse Oximeter Probe Protective Face Shield Medical Goggles Adult SpO2 Finger Sensor Disposable Pressure Infusion Bag; infusor, pressure, for i.v. bags Med-link Pluse Oximeter Interconnect tube Med-link Reusable Blood Pressure Cuff Disposable Gas Sampling Line Incontinence probe Med-link Disposable ECG Cable and Leadwires Med-link Temperature Probes Med-link Wrist Digital Blood Pressure Monitor Med-link Upper Arm Digital Blood Pressure Monitor Hylink Disposable Blood Pressure Cuff Med-linket Disposable Blood Pressure Cuff

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2024-09-05
FYE	Dress, Surgical	General, Plastic Surgery	Class 1	878.4040	2024-09-04
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2024-09-04
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2024-09-03
KZD	Infusor, Pressure, For I.V. Bags	General Hospital	Class 1	880.5420	2024-09-03
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2024-09-04
JFC	System, Pressure Measurement, Intermittent	Physical Medicine	Class 1	890.1600	2024-09-05
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2024-09-04
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2026-02-05
HIR	Perineometer	Obstetrics/Gynecology	Class 2	884.1425	2024-09-04
KPI	Stimulator, Electrical, Non-Implantable, For Incontinence	Gastroenterology, Urology	Class 2	876.5320	2024-09-04
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2024-09-04
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2024-09-04
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2024-09-04
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2024-09-04

Official Correspondent

MARK MA

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MED-LINKET CORP

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
3014652024	CEA GROUP INTERNATIONAL CO.,LTD	Wenzhou Zhejiang, CN
1062836	DIGICARE BIOMEDICAL TECHNOLOGY, INC.	BOYNTON BEACH, FL, US
3013250653	MASIMO CORPORATION	Irvine, CA, US
3013418500	Quintana Supply, a division of Thomas Scientific	Haverhill, MA, US
9614470	RADIOMETER BASEL AG	BASEL Basel-Stadt, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013426279. Last updated year: 2026. Please use registration number 3013426279 when referencing this establishment in official correspondence.