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FDA 510(k)

Disposable Manual Resuscitator

K-Number: K210288 · 2021-08-26

ApplicantXiamen Compower Medical Tech. Co., Ltd.
Decision Date2021-08-26
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Disposable Manual Resuscitator is a medical device manufactured by Xiamen Compower Medical Tech. Co., Ltd.. It received FDA 510(k) clearance on 2021-08-26 under approval number K210288. 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 Disposable Manual Resuscitator?

Disposable Manual Resuscitator is a medical device that received FDA 510(k) clearance on 2021-08-26. It is manufactured by Xiamen Compower Medical Tech. Co., Ltd.. The 510(k) number is K210288.

When was Disposable Manual Resuscitator approved by the FDA?

Disposable Manual Resuscitator received FDA 510(k) clearance on 2021-08-26, under approval number K210288.

What company makes Disposable Manual Resuscitator?

Disposable Manual Resuscitator is manufactured by Xiamen Compower Medical Tech. Co., Ltd..

What is the FDA product code for Disposable Manual Resuscitator?

The FDA product code for Disposable Manual Resuscitator is BTM.

Related Clinical Trials

NCT06849596 Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates RECRUITING

Other Devices by Xiamen Compower Medical Tech. Co., Ltd.

K171961Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm)

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. K170663Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable ManometerForemount Enterprise Co., Ltd. K212905Sotair DeviceSafe Bvm Corporation K221841EOlife®Archeon K251631The BAG manual resuscitator and accessoriesLaerdal Medical AS

Official Source

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

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