FDA 510(k)

Disposable Manual Resuscitator

N.º K: K210288 · 2021-08-26

SolicitanteXiamen Compower Medical Tech. Co., Ltd.

Fecha de decisión2021-08-26

Código de productoBTM

Comité asesorAN

DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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.

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Otros registros que enlistan a Xiamen Compower Medical Tech. Co., Ltd. como solicitante

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)

Dispositivos relacionados (Código: BTM)

K251631The BAG manual resuscitator and accessoriesLaerdal Medical AS K243861butterflyBVMCompact Medical, Inc.K221841EOlife®Archeon K212905Sotair DeviceSafe Bvm Corporation K181583Bolsa de Resucitación de Uso Único para Adultos sin Alivio de Presión, Bolsa de Resucitación de Uso Único + Alivio de Presión 40CMH20, Bolsa de Resucitación de Uso Único + Alivio de Presión 60CMH20, Bolsa de Resucitación de Uso Único Pediátrica + Alivio de Presión 40CMH20, Bolsa de Resucitación de Uso Único para Bebés + Alivio de Presión 40CMH20Flexicare Medical Limited.K170663Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable ManometerForemount Enterprise Co., Ltd.

Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.