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FDA 510(k)

CARDIOX FLOW DETECTION SYSTEM

K-Number: K122400 · 2013-11-05

ApplicantCardiox Corp.
Decision Date2013-11-05
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOX FLOW DETECTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cardiox Corp.. It received FDA 510(k) clearance on 2013-11-05 under 510(k) number K122400. The device is classified under product code DXG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOX FLOW DETECTION SYSTEM?

CARDIOX FLOW DETECTION SYSTEM is a medical device that received FDA 510(k) clearance on 2013-11-05. The listed applicant is Cardiox Corp.. The 510(k) number is K122400.

When did CARDIOX FLOW DETECTION SYSTEM receive FDA 510(k) clearance?

CARDIOX FLOW DETECTION SYSTEM received FDA 510(k) clearance on 2013-11-05, under 510(k) number K122400.

Who is the listed applicant for CARDIOX FLOW DETECTION SYSTEM?

The FDA 510(k) record lists Cardiox Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIOX FLOW DETECTION SYSTEM?

The FDA product code for CARDIOX FLOW DETECTION SYSTEM is DXG.

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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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