FDA 510(k)

Ventilador da Série 731

Número K: K233486 · 2024-12-13

Data da decisão2024-12-13

Código do produtoCBK

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

731 Series Ventilator is the device name listed in this FDA 510(k) record. The listed applicant is ZOLL Medical Corporation. It received FDA 510(k) clearance on 2024-12-13 under 510(k) number K233486. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the 731 Series Ventilator?

731 Series Ventilator is a medical device that received FDA 510(k) clearance on 2024-12-13. The listed applicant is ZOLL Medical Corporation. The 510(k) number is K233486.

When did 731 Series Ventilator receive FDA 510(k) clearance?

731 Series Ventilator received FDA 510(k) clearance on 2024-12-13, under 510(k) number K233486.

Who is the listed applicant for 731 Series Ventilator?

The FDA 510(k) record lists ZOLL Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 731 Series Ventilator?

The FDA product code for 731 Series Ventilator is CBK.

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Outros registros que listam ZOLL Medical Corporation como candidato(a)

K202375ZOLL Propaq M K180482ZOLL Propaq M K172653Power Infuser K162832Ventiladores da Série 731 K170533Model 330 Multifunction Aspirator

Dispositivos Relacionados (Código: CBK)

K253647Evita (V800); Evita (V600)Draegerwerk AG & CO Kgaa K252663Inbentus VersatileIconic Solutions by Murcia, SL K251888VPAP Pediatric Face MaskHsiner Co., Ltd.K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.K252173F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented FullFisher & Paykel Healthcare, Ltd.K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.

Fonte oficial

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