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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 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.

Frequently Asked Questions

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.

Related Devices (Code: QYX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250793RhythmStar System (SL)RhythMedix, LLCK241179Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)VivaQuant, Inc.K240653SmartCardia 7L Platform (MCT)Smartcardia SAK240029Zio AT® device (A100A1001)iRhythm Technologies, Inc.K233584RhythmStar SystemRhythMedix, LLCK170565LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3LLifewatch Services, Inc.

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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