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Data / Medical devices / Taiwan / Foremount Enterprise Co., Ltd.

Foremount Enterprise Co., Ltd.: FDA-registered device maker in Taichung City, Taiwan, 6 510(k) clearances

Foremount Enterprise Co., Ltd. is registered with the FDA (registration 3010402691) in Taichung City, Taiwan. It lists 30 device types. The FDA files 6 510(k) clearances under its listings, the newest dated May 11, 2018. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Foremount Enterprise Co., Ltd.
FDA registration number
3010402691
Address
No. 257, Sec. 5, Changping Rd. Shengang District, Taichung City, Taiwan, 429
Owner or operator
FOREMOUNT ENTERPRISE CO., LTD. (9042153)
Roles
Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler
First device listed
July 13, 2000
Registered through
2026
Brand names listed
Aerosol mask, Air Breathing Bag, Airway, Anesthesia Circuit, Anesthesia Circuit Accessories, Anesthesia Face mask, Anesthesia breathing circuit, Anesthesia mask, Rotation Mask and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessory Equipment, Cardiopulmonary BypassKRI1Contract manufacturer, Manufactureraccessdata.fda.gov
Airway, Oropharyngeal, AnesthesiologyCAE1Contract manufacturer, Manufactureraccessdata.fda.gov
Attachment, Breathing, Positive End Expiratory PressureBYE2Manufactureraccessdata.fda.gov
Bag, ReservoirBTC1Contract manufacturer, Manufactureraccessdata.fda.gov
Cannula, Nasal, OxygenCAT1Contract manufacturer, Manufactureraccessdata.fda.gov
Circuit, Breathing (W Connector, Adaptor, Y Piece)CAI1Contract manufacturer, Manufactureraccessdata.fda.gov
Clip, NoseBXJ1Manufactureraccessdata.fda.gov
Condenser, Heat And Moisture (Artificial Nose)BYD1Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Connector, Airway (Extension)BZA1Contract manufacturer, Manufactureraccessdata.fda.gov
Filter, Bacterial, Breathing-CircuitCAH2Repackager or relabeleraccessdata.fda.gov
Gag, MouthKBN1Contract manufacturer, Manufactureraccessdata.fda.gov
Holding Chambers, Direct Patient InterfaceNVP2Contract manufactureraccessdata.fda.gov
Humidifier, Non-Direct Patient Interface (Home-Use)KFZ1Repackager or relabeleraccessdata.fda.gov
Infusor, Pressure, For I.V. BagsKZD1Contract manufacturer, Manufactureraccessdata.fda.gov
Laryngoscope, RigidCCW1Contract manufacturer, Manufactureraccessdata.fda.gov
Mask, Gas, AnestheticBSJ1Contract manufacturer, Manufactureraccessdata.fda.gov
Mask, OxygenBYG1Contract manufacturer, Manufactureraccessdata.fda.gov
Mask, Oxygen, Low Concentration, VenturiBYF1Contract manufacturer, Manufactureraccessdata.fda.gov
Mask, Oxygen, Non-RebreathingKGB1Contract manufacturer, Manufactureraccessdata.fda.gov
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)CAP2Manufactureraccessdata.fda.gov
Mouthpiece, BreathingBYP1Contract manufactureraccessdata.fda.gov
Nebulizer (Direct Patient Interface)CAF2Repackager or relabeleraccessdata.fda.gov
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)CCQ1Repackager or relabeleraccessdata.fda.gov
Polymer Patient Examination GloveLZA1Exporter to the USaccessdata.fda.gov
Set, Tubing And Support, Ventilator (W Harness)BZO1Contract manufacturer, Manufactureraccessdata.fda.gov
Strap, Head, Gas MaskBTK1Contract manufacturer, Manufactureraccessdata.fda.gov
Stylet, Tracheal TubeBSR1Contract manufacturer, Manufactureraccessdata.fda.gov
Tubing, Pressure And AccessoriesBYX1Contract manufacturer, Manufactureraccessdata.fda.gov
Valve, Non-RebreathingCBP2Manufactureraccessdata.fda.gov
Ventilator, Emergency, Manual (Resuscitator)BTM2Manufacturer, Repackager or relabeleraccessdata.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
May 11, 2018K170663Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable ManometerBTMSubstantially EquivalentForemount Enterprise Co., Ltd.accessdata.fda.gov
April 17, 2013K121770HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZERCAFSubstantially EquivalentHeadstar Medical Products Co., Ltd.accessdata.fda.gov
February 19, 2013K123469POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE AND WHITE COLORED, NON-STERILELZASubstantially EquivalentWear Safe (Malaysia) Sdn Bhd - Facility IIaccessdata.fda.gov
March 18, 2005K042727POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201ACBPSubstantially EquivalentForemount Ent. Co., Ltd.accessdata.fda.gov
September 20, 2004K032878KUNG SHIN, HMEF SK203CAHSubstantially EquivalentKung Shin Plastics Co., Ltd.accessdata.fda.gov
June 6, 2001K002846HEADSTAR'S MANUAL EMERGENCY RESUSCITATORBTMSubstantially EquivalentHeadstar Medical Products Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated May 11, 2018. 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.