FDA 510(k)

Ambu VivaSight 2 DLT, Cabo de Adaptador Ambu VivaSight 2

Número K: K203749 · 2021-05-03

Data da decisão2021-05-03

Código do produtoCBI

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable 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 2021-05-03 under 510(k) number K203749. The device is classified under product code CBI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable?

Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable is a medical device that received FDA 510(k) clearance on 2021-05-03. The listed applicant is Ambu A/S. The 510(k) number is K203749.

When did Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable receive FDA 510(k) clearance?

Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable received FDA 510(k) clearance on 2021-05-03, under 510(k) number K203749.

Who is the listed applicant for Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable?

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 VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable?

The FDA product code for Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable is CBI.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

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 K261400Ambu® aScope™ Gastro; Ambu® aScope™ Gastro Large 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)K251583Filtro de Exalação Ambu® Virobac II®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

Ver todos os 29 dispositivos →

Dispositivos Relacionados (Código: CBI)

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.