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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 the device name listed in this FDA 510(k) record. The listed applicant is Xiamen Compower Medical Tech. Co., Ltd.. It received FDA 510(k) clearance on 2021-08-26 under 510(k) 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. The listed applicant is Xiamen Compower Medical Tech. Co., Ltd.. The 510(k) number is K210288.

When did Disposable Manual Resuscitator receive FDA 510(k) clearance?

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

Who is the listed applicant for Disposable Manual Resuscitator?

The FDA 510(k) record lists Xiamen Compower Medical Tech. Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Manual Resuscitator?

The FDA product code for Disposable Manual Resuscitator is BTM.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06261619Superiority Trial Between Sotair® Device Attached to Manual Resuscitator Versus Ventilation AloneCOMPLETED

Other records listing Xiamen Compower Medical Tech. Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251631The BAG manual resuscitator and accessoriesLaerdal Medical ASK243861butterflyBVMCompact Medical, Inc.K221841EOlife®ArcheonK212905Sotair DeviceSafe Bvm CorporationK181583Adult 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.

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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