NEURO CHECK DEVICE WITH IO-FLEX WIRE— 510(k) K113533

Name: FDA 510(k) clearance K113533
Creator: U.S. Food and Drug Administration
Published: 2012-04-11

Substantially Equivalent

Baxano, Inc.

FDA 510(k) clearance K113533 for NEURO CHECK DEVICE WITH IO-FLEX WIRE, Substantially Equivalent on 2012-04-11. Applicant: Baxano, Inc.. Device class: 2.

Clearance details

Applicant: Baxano, Inc.
Product code: Code HAE
Device class: Class 2
Regulation: 21 CFR 882.4840
Advisory panel: Neurology
Date received: 2011-11-30
Decision date: 2012-04-11
Decision: Substantially Equivalent
Clearance type: Special
Location: San Jose, CA, 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.