FDA 510(k)

Quadro de Fixação de Cabeça Arcus

Número K: K191701 · 2019-11-15

Data da decisão2019-11-15

Código do produtoHBL

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Arcus Head Fixation Frame is the device name listed in this FDA 510(k) record. The listed applicant is Mri Interventions, Inc.. It received FDA 510(k) clearance on 2019-11-15 under 510(k) number K191701. The device is classified under product code HBL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Arcus Head Fixation Frame?

Arcus Head Fixation Frame is a medical device that received FDA 510(k) clearance on 2019-11-15. The listed applicant is Mri Interventions, Inc.. The 510(k) number is K191701.

When did Arcus Head Fixation Frame receive FDA 510(k) clearance?

Arcus Head Fixation Frame received FDA 510(k) clearance on 2019-11-15, under 510(k) number K191701.

Who is the listed applicant for Arcus Head Fixation Frame?

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

What is the FDA product code for Arcus Head Fixation Frame?

The FDA product code for Arcus Head Fixation Frame is HBL.

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