FDA 510(k)

PC ECG

Número K: K152427 · 2016-02-05

Data da decisão2016-02-05

Código do produtoDPS

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

PC ECG is the device name listed in this FDA 510(k) record. The listed applicant is Edan Instruments, Inc.. It received FDA 510(k) clearance on 2016-02-05 under 510(k) number K152427. 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 PC ECG?

PC ECG is a medical device that received FDA 510(k) clearance on 2016-02-05. The listed applicant is Edan Instruments, Inc.. The 510(k) number is K152427.

When did PC ECG receive FDA 510(k) clearance?

PC ECG received FDA 510(k) clearance on 2016-02-05, under 510(k) number K152427.

Who is the listed applicant for PC ECG?

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

What is the FDA product code for PC ECG?

The FDA product code for PC ECG is DPS.

Outros registros que listam Edan Instruments, Inc. como candidato(a)

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Fonte oficial

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