FDA 510(k)

Sterile LeadConfirm

Número K: K191739 · 2020-01-02

RequerenteAlpha Omega Engineering , Ltd.

Data da decisão2020-01-02

Código do produtoGZL

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Sterile LeadConfirm is the device name listed in this FDA 510(k) record. The listed applicant is Alpha Omega Engineering , Ltd.. It received FDA 510(k) clearance on 2020-01-02 under 510(k) number K191739. The device is classified under product code GZL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Sterile LeadConfirm?

Sterile LeadConfirm is a medical device that received FDA 510(k) clearance on 2020-01-02. The listed applicant is Alpha Omega Engineering , Ltd.. The 510(k) number is K191739.

When did Sterile LeadConfirm receive FDA 510(k) clearance?

Sterile LeadConfirm received FDA 510(k) clearance on 2020-01-02, under 510(k) number K191739.

Who is the listed applicant for Sterile LeadConfirm?

The FDA 510(k) record lists Alpha Omega Engineering , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile LeadConfirm?

The FDA product code for Sterile LeadConfirm is GZL.

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Outros registros que listam Alpha Omega Engineering , Ltd. como candidato(a)

K250601Neuro Omega System; NeuroSmart System K220553Neuro Omega System, NeuroSmart System K172042NeuroNav System, NeuroSmart System K171581Neuro Omega System

Dispositivos Relacionados (Código: GZL)

Fonte oficial

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