Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004415095

FEI Number

3004415095

Entity Name

Industrial Vallera de Mexicali, S. A. de C. V.

City/State/Country

Mexicali Mexico, MX

Establishment Address

Calzada del Oro no. 2001, Parque Industrial Palaco, Mexicali Mexico 21600, MX

Establishment Type(s)

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

K123043

PMA Number

N/A

All Registered Proprietary Names

MLNCS E1 LNCS E1 Stork Hub Stork Vitals Stork Vitals+ Stork Sensor LNCS Reprocessed Sterile Sensors SedLine Sensors SedLine Module RD SedLine Sensors RD SET Neo rainbow SpHb Disposable Sensors Rad-57 LNCS-II rainbow DCI 8 Lambda rainbow DCI rainbow DCI SC O3 Sensor O3 Regional Oximetry Direct Connect Sensors SatShare Cables Masimo SET Radical Pulse Oximeter with SatShare Radius T RD rainbow Lite SET-1 RD rainbow 4 Lambda RD rainbow SET-2 RD SET CS Disposable Sensors LNCS Disposable Sensors M-LNCS Disposable Sensors RD SET TF-I M-LNCS TF-I LNCS TF-I Pronto rainbow DCI-mini Rad-67 MAC Adapter Cable AC-1 Adapter Cable Rainbow ReSposable Sensors Rainbow ReSposable U Sensors SpO2.com Sensors MightySat Medical Masimo SafetyNet LNCS Sterile Sensors MightySat Rx Pronto M-LNCS Blue LNCS Blue RD SET TFA-1 M-LNCS TFA-1 LNCS TFA-1 M-LNCS Red TFA-1 Radius-7 Masimo SET Rad 57 cm Pulse CO-Oximeter Masimo SET Rad 57 m Pulse CO-Oximeter Masimo SET Red reusable sensors uSpO2 Cables LNCS YI M-LNCS YI NomoLine ISA CO2 NomoLine-O Accessories ISA CO2 Module NomoLine ISA OR+ NomoLine ISA AX+ NomoLine Accessories ISA AX+ Module EMMA Airway Adapter Radius PCG EMMA RD SET Multisite Reusable sensors RD Speciality sensors RD SET Reusable sensors RD SET Disposable sensors Rad-5v Rad-5 rainbow SpCO Disposable Sensors LNCS-II rainbow 8 Lambda RD rainbow 8 Lambda RD SET DBI DBI-dc LNCS DBI Red DBI M-LNCS DBI M-LNCS Sterile Sensors M-LNCS Reprocessed Sterile Sensors RAS-125 RAS-125c RAS-45 LiDCOunity v2 Hemodynamic Monitor LiDCO Module Red MNC Cable NC Adapter Cable MNC Cable IRMA Airway Adapter IRMA AX+ IRMA CO2

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
QYU	Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use	Cardiovascular	Class 2	870.2705	2024-08-14
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2024-08-14
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2011-02-14
ORT	Burst Suppression Detection Software For Electroencephalograph	Neurology	Class 2	882.1400	2022-03-22
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2022-03-22
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2022-03-22
OLW	Index-Generating Electroencephalograph Software	Neurology	Class 2	882.1400	2022-03-22
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2022-03-22
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
JKS	Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide	Clinical Toxicology	Class 1	862.3220	2011-02-14
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2011-02-14
DPZ	Oximeter, Ear	Cardiovascular	Class 2	870.2710	2011-02-14
JKS	Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide	Clinical Toxicology	Class 1	862.3220	2011-02-14
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2011-02-14
DPZ	Oximeter, Ear	Cardiovascular	Class 2	870.2710	2011-02-14
MUD	Oximeter, Tissue Saturation	Cardiovascular	Class 2	870.2700	2023-04-28
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2011-02-14
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2021-07-07
QWE	Hyperoxia Monitoring Device Adjunct To Pulse Oximetry	Anesthesiology	Class 2	870.2720	2024-06-25
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2011-02-14
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2011-02-14
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2011-02-14
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2019-08-07
DQA	Oximeter	Cardiovascular	Class 2	870.2700	1999-12-30
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2010-12-06
JKS	Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide	Clinical Toxicology	Class 1	862.3220	2010-12-06
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2010-12-06
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2011-02-14
OLK	Pulse Oximeter For Over-The-Counter Use	Cardiovascular	Class 2	870.2700	2024-02-15
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2013-07-12
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2011-02-14
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2019-02-12
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2019-02-12
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2011-02-14
DQA	Oximeter	Cardiovascular	Class 2	870.2700	1999-12-30
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2017-02-22
JKS	Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide	Clinical Toxicology	Class 1	862.3220	2021-03-09
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2021-03-09
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2021-03-09
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2021-03-09
DPZ	Oximeter, Ear	Cardiovascular	Class 2	870.2710	2021-03-09
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2021-03-09
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2021-03-09
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2021-03-09
DQA	Oximeter	Cardiovascular	Class 2	870.2700	1999-12-30
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2014-06-24
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2011-12-14
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2018-05-15
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2018-05-15
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2018-05-15
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2018-05-15
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2018-05-15
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2018-05-15
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2018-05-15
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2018-05-15
OLW	Index-Generating Electroencephalograph Software	Neurology	Class 2	882.1400	2018-05-15
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2018-05-15
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2018-05-15
ORT	Burst Suppression Detection Software For Electroencephalograph	Neurology	Class 2	882.1400	2018-05-15
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2018-05-15
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2018-05-15
DPZ	Oximeter, Ear	Cardiovascular	Class 2	870.2710	2018-05-15
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2018-05-15
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2018-05-15
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2018-05-15
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2018-05-15
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2018-05-15
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2018-05-15
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2021-06-22
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2019-08-12
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2011-02-14
DPZ	Oximeter, Ear	Cardiovascular	Class 2	870.2710	2011-02-14
JKS	Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide	Clinical Toxicology	Class 1	862.3220	2007-07-20
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2007-07-20
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2014-06-24
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2011-09-06
NLF	Oximeter, Reprocessed	Cardiovascular	Class 2	870.2700	2011-09-06
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2011-09-06
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2013-08-26
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2013-08-26
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2023-02-23
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2023-02-23
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2023-02-23
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2011-02-14
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2022-03-28
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2022-03-28
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2022-03-28
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2022-03-28
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2022-03-28
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2022-03-28
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2022-03-28

Official Correspondent

No official correspondent registered.

US Agent Details

Mathew Jimenez Email: MJimenez@masimo.com Phone: (949) 2977558

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
3027256461	Masimo Medical Technologies (Malaysia) SDN BHD	Pasir Gudang Johor, MY
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

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

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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 3004415095. Last updated year: 2026. Please use registration number 3004415095 when referencing this establishment in official correspondence.