FDA 510(k)

Medax Biopsy Systems III

Número K: K181803 · 2018-10-18

Data da decisão2018-10-18

Código do produtoKNW

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Medax Biopsy Systems III is the device name listed in this FDA 510(k) record. The listed applicant is Medax Srl Unipersonale. It received FDA 510(k) clearance on 2018-10-18 under 510(k) number K181803. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Medax Biopsy Systems III?

Medax Biopsy Systems III is a medical device that received FDA 510(k) clearance on 2018-10-18. The listed applicant is Medax Srl Unipersonale. The 510(k) number is K181803.

When did Medax Biopsy Systems III receive FDA 510(k) clearance?

Medax Biopsy Systems III received FDA 510(k) clearance on 2018-10-18, under 510(k) number K181803.

Who is the listed applicant for Medax Biopsy Systems III?

The FDA 510(k) record lists Medax Srl Unipersonale as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medax Biopsy Systems III?

The FDA product code for Medax Biopsy Systems III is KNW.

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Outros registros que listam Medax Srl Unipersonale como candidato(a)

K192099MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System K192101Medone Ultra, Medextra K172344Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)

Dispositivos Relacionados (Código: KNW)

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