FDA 510(k)

Filtro de Exalação Ambu® Virobac II®

Número K: K251583 · 2026-04-30

Data da decisão2026-04-30

Código do produtoCAH

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Ambu® Virobac II® Exhalation Filter is the device name listed in this FDA 510(k) record. The listed applicant is Ambu A/S. It received FDA 510(k) clearance on 2026-04-30 under 510(k) number K251583. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Ambu® Virobac II® Exhalation Filter?

Ambu® Virobac II® Exhalation Filter is a medical device that received FDA 510(k) clearance on 2026-04-30. The listed applicant is Ambu A/S. The 510(k) number is K251583.

When did Ambu® Virobac II® Exhalation Filter receive FDA 510(k) clearance?

Ambu® Virobac II® Exhalation Filter received FDA 510(k) clearance on 2026-04-30, under 510(k) number K251583.

Who is the listed applicant for Ambu® Virobac II® Exhalation Filter?

The FDA 510(k) record lists Ambu A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ambu® Virobac II® Exhalation Filter?

The FDA product code for Ambu® Virobac II® Exhalation Filter is CAH.

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Outros registros que listam Ambu A/S como candidato(a)

K261400Ambu® aScope™ Gastro; Ambu® aScope™ Gastro Large K260309Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set K260578Ambu® NeurolineTM Copo MRI/CT (Modelos 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Copo MRI/CT-conjunto (Modelos 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Copo MRI/CT-mini conjunto (Modelos 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)K250269Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection)K240849Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aBox™ 2 K240848Ambu® aScope™ 5 Cysto HD (Desvio Standard); Ambu® aScope™ 5 Cysto HD (Desvio Inverso); Ambu® aView™ 2 Advance

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Fonte oficial

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