FDA 510(k)

NOWCARDIO SYSTEM

Número K: K162956 · 2017-09-22

RequerenteContex International Technologies (Canada), Inc.

Data da decisão2017-09-22

Código do produtoQYX

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

NOWCARDIO SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Contex International Technologies (Canada), Inc.. It received FDA 510(k) clearance on 2017-09-22 under 510(k) number K162956. The device is classified under product code QYX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the NOWCARDIO SYSTEM?

NOWCARDIO SYSTEM is a medical device that received FDA 510(k) clearance on 2017-09-22. The listed applicant is Contex International Technologies (Canada), Inc.. The 510(k) number is K162956.

When did NOWCARDIO SYSTEM receive FDA 510(k) clearance?

NOWCARDIO SYSTEM received FDA 510(k) clearance on 2017-09-22, under 510(k) number K162956.

Who is the listed applicant for NOWCARDIO SYSTEM?

The FDA 510(k) record lists Contex International Technologies (Canada), Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NOWCARDIO SYSTEM?

The FDA product code for NOWCARDIO SYSTEM is QYX.

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