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FDA 510(k)

NOWCARDIO SYSTEM

K-Number: K162956 · 2017-09-22

ApplicantContex International Technologies (Canada), Inc.
Decision Date2017-09-22
Product CodeQYX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

What is the NOWCARDIO SYSTEM?

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

When was NOWCARDIO SYSTEM approved by the FDA?

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

What company makes NOWCARDIO SYSTEM?

NOWCARDIO SYSTEM is manufactured by Contex International Technologies (Canada), Inc..

What is the FDA product code for NOWCARDIO SYSTEM?

The FDA product code for NOWCARDIO SYSTEM is QYX.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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