CARDIOX FLOW DETECTION SYSTEM— 510(k) K122400

Substantially Equivalent

Cardiox Corp.

FDA 510(k) clearance K122400 for CARDIOX FLOW DETECTION SYSTEM, Substantially Equivalent on 2013-11-05. Applicant: Cardiox Corp.. Device class: 2.

Clearance details

Applicant: Cardiox Corp.
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 2012-08-07
Decision date: 2013-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbus, OH, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.