CORTEX ID SUITE— 510(k) K141074

Substantially Equivalent

Ge Medical Systems, LLC

FDA 510(k) clearance K141074 for CORTEX ID SUITE, Substantially Equivalent on 2014-09-18. Applicant: Ge Medical Systems, LLC. Device class: 2.

Clearance details

Applicant: Ge Medical Systems, LLC
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2014-04-25
Decision date: 2014-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukesha, WI, 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.