FDA 510(k)

Quantitative Electrocardiographic Detector (QED 2000)

Número K: K152135 · 2016-08-09

Data da decisão2016-08-09

Código do produtoDPS

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Quantitative Electrocardiographic Detector (QED 2000) is the device name listed in this FDA 510(k) record. The listed applicant is Acme Portable Machines, Inc.. It received FDA 510(k) clearance on 2016-08-09 under 510(k) number K152135. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Quantitative Electrocardiographic Detector (QED 2000)?

Quantitative Electrocardiographic Detector (QED 2000) is a medical device that received FDA 510(k) clearance on 2016-08-09. The listed applicant is Acme Portable Machines, Inc.. The 510(k) number is K152135.

When did Quantitative Electrocardiographic Detector (QED 2000) receive FDA 510(k) clearance?

Quantitative Electrocardiographic Detector (QED 2000) received FDA 510(k) clearance on 2016-08-09, under 510(k) number K152135.

Who is the listed applicant for Quantitative Electrocardiographic Detector (QED 2000)?

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

What is the FDA product code for Quantitative Electrocardiographic Detector (QED 2000)?

The FDA product code for Quantitative Electrocardiographic Detector (QED 2000) is DPS.

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