Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027256461

FEI Number

3027256461

Entity Name

Masimo Medical Technologies (Malaysia) SDN BHD

City/State/Country

Pasir Gudang Johor, MY

Establishment Address

Lot 198511 (PLO 547-A) & Lot 198512 (PLO 547-B), Jalan Keluli 11, Zon 12A Kawasan Perindustrian Pasir Gudang, Pasir Gudang Johor 81700, MY

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

MASIMO CORPORATION (Owner Number: 9031881)

Owner / Operator Contact Address

52 Discovery, --, Irvine, CA 92618, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K051212

PMA Number

N/A

All Registered Proprietary Names

MLNCS E1 LNCS E1 M-LNCS Blue LNCS Blue RD SET Multisite Reusable sensors RD Speciality sensors RD SET Reusable sensors RD SET Disposable sensors RD SET Neo RD SET DBI DBI-dc LNCS DBI Red DBI M-LNCS DBI RD SET CS Disposable Sensors LNCS Disposable Sensors M-LNCS Disposable Sensors RD SET TFA-1 M-LNCS TFA-1 LNCS TFA-1 M-LNCS Red TFA-1 LNCS YI M-LNCS YI Red Reusable Sensors LNCS Reusable Sensors M-LNCS Reusable Sensors

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2014-06-24
DQA	Oximeter	Cardiovascular	Class 2	870.2700	1999-12-30
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2019-08-12
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2021-05-14
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2021-05-14
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2021-05-14
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2021-05-14
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2021-05-14
JKS	Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide	Clinical Toxicology	Class 1	862.3220	2021-05-14
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2021-05-14
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2014-06-24
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2011-02-14
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2017-02-22
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2011-12-14
DQA	Oximeter	Cardiovascular	Class 2	870.2700	1999-12-30

Official Correspondent

Mathew Jimenez

US Agent Details

Mathew Jimenez Business: MASIMO CORPORATION Email: mjimenez@masimo.com Phone: (949) 2977000

Related Public Records

Same Entity

MASIMO CORPORATION

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3013250653	MASIMO CORPORATION	Irvine, CA, US
3009831876	MASIMO CORPORATION	Irvine, CA, US
3011353843	MASIMO CORPORATION	Irvine, CA, US
3016674095	Industrial Vallera de Mexicali, S.A. de C.V. (Terra)	Mexicali Baja California, MX
3004415095	Industrial Vallera de Mexicali, S. A. de C. V.	Mexicali Mexico, MX

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 3027256461. Last updated year: 2026. Please use registration number 3027256461 when referencing this establishment in official correspondence.