FDA 510(k)

OsteoCool V-3 RF Ablation System

Número K: K161949 · 2017-01-31

Data da decisão2017-01-31

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

OsteoCool V-3 RF Ablation System is the device name listed in this FDA 510(k) record. The listed applicant is Baylis Medical Company, Inc.. It received FDA 510(k) clearance on 2017-01-31 under 510(k) number K161949. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the OsteoCool V-3 RF Ablation System?

OsteoCool V-3 RF Ablation System is a medical device that received FDA 510(k) clearance on 2017-01-31. The listed applicant is Baylis Medical Company, Inc.. The 510(k) number is K161949.

When did OsteoCool V-3 RF Ablation System receive FDA 510(k) clearance?

OsteoCool V-3 RF Ablation System received FDA 510(k) clearance on 2017-01-31, under 510(k) number K161949.

Who is the listed applicant for OsteoCool V-3 RF Ablation System?

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

What is the FDA product code for OsteoCool V-3 RF Ablation System?

The FDA product code for OsteoCool V-3 RF Ablation System is GEI.

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Fonte oficial

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