FDA 510(k)

KardioScreen

Número K: K191692 · 2020-01-10

RequerenteImedrix Inc. (Formerly Piitech Inc.)

Data da decisão2020-01-10

Código do produtoDPS

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

KardioScreen is the device name listed in this FDA 510(k) record. The listed applicant is Imedrix Inc. (Formerly Piitech Inc.). It received FDA 510(k) clearance on 2020-01-10 under 510(k) number K191692. 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 KardioScreen?

KardioScreen is a medical device that received FDA 510(k) clearance on 2020-01-10. The listed applicant is Imedrix Inc. (Formerly Piitech Inc.). The 510(k) number is K191692.

When did KardioScreen receive FDA 510(k) clearance?

KardioScreen received FDA 510(k) clearance on 2020-01-10, under 510(k) number K191692.

Who is the listed applicant for KardioScreen?

The FDA 510(k) record lists Imedrix Inc. (Formerly Piitech Inc.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KardioScreen?

The FDA product code for KardioScreen is DPS.

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