FDA 510(k)

Certus 140 2.45GHz Ablation System

Número K: K173756 · 2018-10-24

Data da decisão2018-10-24

Código do produtoNEY

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Certus 140 2.45GHz Ablation System is the device name listed in this FDA 510(k) record. The listed applicant is Neuwave Medical, Inc.. It received FDA 510(k) clearance on 2018-10-24 under 510(k) number K173756. The device is classified under product code NEY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Certus 140 2.45GHz Ablation System?

Certus 140 2.45GHz Ablation System is a medical device that received FDA 510(k) clearance on 2018-10-24. The listed applicant is Neuwave Medical, Inc.. The 510(k) number is K173756.

When did Certus 140 2.45GHz Ablation System receive FDA 510(k) clearance?

Certus 140 2.45GHz Ablation System received FDA 510(k) clearance on 2018-10-24, under 510(k) number K173756.

Who is the listed applicant for Certus 140 2.45GHz Ablation System?

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

What is the FDA product code for Certus 140 2.45GHz Ablation System?

The FDA product code for Certus 140 2.45GHz Ablation System is NEY.

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Outros registros que listam Neuwave Medical, Inc. como candidato(a)

K232227ABLATE-IQ K231738NEUWAVE™ Microwave Ablation System and Accessories K220472NEUWAVE Microwave Ablation System and Accessories K200081NEUWAVE Microwave Ablation System and Accessories K192427Ablation Confirmation K171022Ablation Confirmation

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Dispositivos Relacionados (Código: NEY)

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Fonte oficial

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