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FDA 510(k)

Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer

K-Number: K170663 · 2018-05-11

ApplicantForemount Enterprise Co., Ltd.
Decision Date2018-05-11
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer is a medical device manufactured by Foremount Enterprise Co., Ltd.. It received FDA 510(k) clearance on 2018-05-11 under approval number K170663. The device is classified under product code BTM. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer?

Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer is a medical device that received FDA 510(k) clearance on 2018-05-11. It is manufactured by Foremount Enterprise Co., Ltd.. The 510(k) number is K170663.

When was Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer approved by the FDA?

Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer received FDA 510(k) clearance on 2018-05-11, under approval number K170663.

What company makes Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer?

Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer is manufactured by Foremount Enterprise Co., Ltd..

What is the FDA product code for Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer?

The FDA product code for Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer is BTM.

Related Devices (Code: BTM)

K152931Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant ResuscitatorAmbu A/S K181583Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20Flexicare Medical Limited. K210288Disposable Manual ResuscitatorXiamen Compower Medical Tech. Co., Ltd. K212905Sotair DeviceSafe Bvm Corporation K221841EOlife®Archeon K251631The BAG manual resuscitator and accessoriesLaerdal Medical AS

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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