FDA 510(k)

CT Midline

Número K: K170770 · 2017-07-25

RequerenteMedical Components, Inc. (dba MedComp)

Data da decisão2017-07-25

Código do produtoPND

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

CT Midline is the device name listed in this FDA 510(k) record. The listed applicant is Medical Components, Inc. (dba MedComp). It received FDA 510(k) clearance on 2017-07-25 under 510(k) number K170770. The device is classified under product code PND. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CT Midline?

CT Midline is a medical device that received FDA 510(k) clearance on 2017-07-25. The listed applicant is Medical Components, Inc. (dba MedComp). The 510(k) number is K170770.

When did CT Midline receive FDA 510(k) clearance?

CT Midline received FDA 510(k) clearance on 2017-07-25, under 510(k) number K170770.

Who is the listed applicant for CT Midline?

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

What is the FDA product code for CT Midline?

The FDA product code for CT Midline is PND.

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Fonte oficial

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