EMORY CARDIAC TOOLBOX 4.0— 510(k) K123646

Substantially Equivalent

Syntermed, Inc.

FDA 510(k) clearance K123646 for EMORY CARDIAC TOOLBOX 4.0, Substantially Equivalent on 2013-02-22. Applicant: Syntermed, Inc.. Device class: 2.

Clearance details

Applicant: Syntermed, Inc.
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2012-11-27
Decision date: 2013-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anaheim, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Syntermed, Inc.

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