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

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..

Clearance details

Applicant: Baxano, Inc.
Product code: Code HAE
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 ↗

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