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Data / Medical devices / Mexico / Salter Labs de Mexico de S.A. de C.V.

Salter Labs de Mexico de S.A. de C.V.: FDA-registered device maker in Chihuahua Mexico, Mexico, 34 510(k) clearances

Salter Labs de Mexico de S.A. de C.V. is registered with the FDA (registration 3010272829) in Chihuahua Mexico, Mexico. It lists 29 device types. The FDA files 34 510(k) clearances under its listings, the newest dated September 21, 2017. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Salter Labs de Mexico de S.A. de C.V.
FDA registration number
3010272829
Address
Blvd. Independencia #2167 Parque Ind. Las Americas - Horizonte Sur. Cd. Juarez, Chihuahua Mexico, Mexico, 32596
Owner or operator
SunMed "also trading as AirLife" (9038422)
Roles
Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed
December 21, 1992
Registered through
2027
Brand names listed
ACCU-FLOW Venturi Oxygen System, Airflow resuscitator, BiNAPS® Nasal Airflow Pressure and Snore Transducer, CO2 Comfort Soft Plus Cannula, CPAP Cannulaide®, Cannula, Nasal, Oxygen, with E-Z wraps, Capnovue, Comfort Soft Plus and more

Devices it lists

DeviceProduct codeClassRoleSource
Analyzer, Gas, Carbon-Dioxide, Gaseous-PhaseCCK2Contract manufacturer, Manufactureraccessdata.fda.gov
Analyzer, Gas, Oxygen, Gaseous-PhaseCCL2Manufactureraccessdata.fda.gov
Blanket, Neonatal PhototherapyPDH2Repackager or relabeleraccessdata.fda.gov
Blood Pressure CuffDXQ2Manufactureraccessdata.fda.gov
Cannula, Nasal, OxygenCAT1Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Chamber, Oxygen, Topical, ExtremityKPJ2Contract manufactureraccessdata.fda.gov
Connector, Airway (Extension)BZA1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Conserver, OxygenNFB2Contract manufacturer, Manufactureraccessdata.fda.gov
Device, Fixation, Tracheal TubeCBH1Manufactureraccessdata.fda.gov
Drain, Tee (Water Trap)BYH1Manufactureraccessdata.fda.gov
Flowmeter, Calibration, GasBXY1Manufactureraccessdata.fda.gov
Humidifier, Respiratory Gas, (Direct Patient Interface)BTT2Contract manufacturer, Manufactureraccessdata.fda.gov
Infusor, Pressure, For I.V. BagsKZD1Manufactureraccessdata.fda.gov
Laryngoscope, RigidCCW1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Mask, OxygenBYG1Manufactureraccessdata.fda.gov
Mask, Oxygen, Low Concentration, VenturiBYF1Manufactureraccessdata.fda.gov
Mask, Oxygen, Non-RebreathingKGB1Manufactureraccessdata.fda.gov
Meter, Peak Flow, SpirometryBZH2Manufactureraccessdata.fda.gov
Monitor, Breathing FrequencyBZQ2Manufactureraccessdata.fda.gov
Nebulizer (Direct Patient Interface)CAF2Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)CCQ1Manufactureraccessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY1Contract manufactureraccessdata.fda.gov
Spirometer, DiagnosticBZG2Manufactureraccessdata.fda.gov
Spirometer, Therapeutic (Incentive)BWF2Repackager or relabeleraccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Tubing, Pressure And AccessoriesBYX1Manufactureraccessdata.fda.gov
Ventilator, Emergency, Manual (Resuscitator)BTM2Contract manufactureraccessdata.fda.gov
Ventilator, Non-Continuous (Respirator)BZD2Repackager or relabeleraccessdata.fda.gov
Ventilatory Effort RecorderMNR2Contract manufacturer, Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
September 21, 2017K161719Salter Labs Bubble HumidifierBTTSubstantially EquivalentSalter Labsaccessdata.fda.gov
December 14, 2016K162343Westmed Gas Sampling Cannula with O2 deliveryCCKSubstantially EquivalentWestmed, Inc.accessdata.fda.gov
April 15, 2016K151874BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/NasalMNRSubstantially EquivalentSalter Labsaccessdata.fda.gov
March 11, 2016K151506Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen CannulaNFBSubstantially EquivalentSalter Labsaccessdata.fda.gov
March 10, 2016K151421Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample LinesCCKSubstantially EquivalentSalter Labsaccessdata.fda.gov
August 5, 2015K143700CPAP CannulaideBZDSubstantially EquivalentSalter Labsaccessdata.fda.gov
June 12, 2015K142416Luma WrapPDHSubstantially EquivalentSalter Labsaccessdata.fda.gov
December 31, 2013K133806M1 CAPNOGRAPHY MASKCCKSubstantially EquivalentMonitor Mask, Inc.accessdata.fda.gov
February 10, 2012K113542SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW)BTTSubstantially EquivalentSalter Labs, Arvin Facilityaccessdata.fda.gov
November 24, 2009K092685PNEUMOTHERML, MODEL: 5800BZQSubstantially EquivalentSalter Labsaccessdata.fda.gov
December 19, 2008K082630VITALCHECK BLOOD PRESSURE CUFF, MODEL ZVC4000 SERIESDXQSubstantially EquivalentZefon Intl.accessdata.fda.gov
July 25, 2008K080922SALTER LABS ORAL/NASAL THERMAL AIRFLOW SENSORBZQSubstantially EquivalentSalter Labs, Division of Regulatory Affairsaccessdata.fda.gov
June 9, 2008K080366DURACHECK BLOOD PRESSURE CUFF, MODEL ZDC4000 SERIESDXQSubstantially EquivalentZefon Intl.accessdata.fda.gov
September 15, 2005K051313BI-NAPS NASAL AIRFLOW AND SNORE TRANSDUCERMNRSubstantially EquivalentSalter Labsaccessdata.fda.gov
February 16, 2005K050104APEX MEDICAL MININEB & MINIPLUSCAFSubstantially EquivalentApex Medical Corp.accessdata.fda.gov
January 7, 2000K992285SALTER AIRE COMPRESSORCAFSubstantially EquivalentSalter Labsaccessdata.fda.gov
September 24, 1999K992986SALTER LABS SINGLE PATIENT USE EXHALATION AEROSOL FILTERCAFSubstantially EquivalentSalter Labsaccessdata.fda.gov
August 6, 1999K991788SALTER LABS PEP DEVICECAFSubstantially EquivalentSalter Labsaccessdata.fda.gov
April 2, 1999K983467THERAPEPBWFSubstantially EquivalentDhd Healthcare Corp.accessdata.fda.gov
March 17, 1999K983500PRO2 CHECK OXYGEN INDICATORCCLSubstantially EquivalentMedical Technology Specialists, Inc.accessdata.fda.gov
December 17, 1998K983403SALTER LABS NEBULIZER EXHALATION AEROSOL FILTERCAFSubstantially EquivalentSalter Labsaccessdata.fda.gov
October 22, 1996K962879SALTERLABS 8660 SERIES NEBULIZERCAFSubstantially EquivalentSalter Labsaccessdata.fda.gov
July 16, 1996K961476SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984)CAFSubstantially EquivalentSalter Labsaccessdata.fda.gov
March 29, 1996K952713MINI WRIGHT LR AFSBZHSubstantially EquivalentClement Clarke, Inc.accessdata.fda.gov
July 2, 1993K930957ZEFON GAS SAMPLING LINESCCKUnknownZefon Medical Productsaccessdata.fda.gov
July 23, 1992K921997CUFF-MDXQSubstantially EquivalentLorin Medical, Inc.accessdata.fda.gov
October 18, 1991K913421NASAL OXYGEN CANNULA, 81585, 81587 & 81589CATSubstantially EquivalentSpecialty Packaging Producs, Inc.accessdata.fda.gov
July 24, 1991K911740SALTER LABS NEONATAL NASAL OXYGEN CANNULACATSubstantially EquivalentSalter Labsaccessdata.fda.gov
July 19, 1991K912633SALTER LABS INFANT MEDIUM CONCENTRATION MASKBYGSubstantially EquivalentSalter Labsaccessdata.fda.gov
December 17, 1990K903539SALTER LABS MODEL #1015CBHSubstantially EquivalentSalter Labsaccessdata.fda.gov
March 16, 1987K870027HAND HELD PHEUMATIC POWERED (DISPOSABLE) NEBULIZERCCQSubstantially EquivalentSalter Labsaccessdata.fda.gov
October 6, 1986K863656SALTER VOLUCHEK 6600BZGSubstantially EquivalentSalter Labsaccessdata.fda.gov
September 18, 1986K863432OXYGEN CANNULA EAR WRAP (STYLE B)CATSubstantially EquivalentSalter Labsaccessdata.fda.gov
January 3, 1978K772127OXYGEN MASK, AIR-ENTRAINMENTBYFSubstantially EquivalentSalter Labsaccessdata.fda.gov

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Updated September 21, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.