FDA 510(k)

Celerity ECG Cable Accessory Pack

Número K: K171931 · 2017-10-26

RequerenteMedcomp (Medical Components, Inc.)

Data da decisão2017-10-26

Código do produtoLJS

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Celerity ECG Cable Accessory Pack is the device name listed in this FDA 510(k) record. The listed applicant is Medcomp (Medical Components, Inc.). It received FDA 510(k) clearance on 2017-10-26 under 510(k) number K171931. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Celerity ECG Cable Accessory Pack?

Celerity ECG Cable Accessory Pack is a medical device that received FDA 510(k) clearance on 2017-10-26. The listed applicant is Medcomp (Medical Components, Inc.). The 510(k) number is K171931.

When did Celerity ECG Cable Accessory Pack receive FDA 510(k) clearance?

Celerity ECG Cable Accessory Pack received FDA 510(k) clearance on 2017-10-26, under 510(k) number K171931.

Who is the listed applicant for Celerity ECG Cable Accessory Pack?

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

What is the FDA product code for Celerity ECG Cable Accessory Pack?

The FDA product code for Celerity ECG Cable Accessory Pack is LJS.

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