SimulCare II(TM)— 510(k) K160246

Substantially Equivalent

Xanacare Technologies, LLC

FDA 510(k) clearance K160246 for SimulCare II(TM), Substantially Equivalent on 2016-10-06. Applicant: Xanacare Technologies, LLC. Device class: 2.

Clearance details

Applicant: Xanacare Technologies, LLC
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2016-02-01
Decision date: 2016-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denver, CO, 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.