MRII Cranial Drill and Accessories— 510(k) K160129

Name: FDA 510(k) clearance K160129
Creator: U.S. Food and Drug Administration
Published: 2016-03-26

Substantially Equivalent

Mri Interventions, Inc.

FDA 510(k) clearance K160129 for MRII Cranial Drill and Accessories, Substantially Equivalent on 2016-03-26. Applicant: Mri Interventions, Inc.. Device class: 2.

Clearance details

Applicant: Mri Interventions, Inc.
Product code: Code HBG
Device class: Class 2
Regulation: 21 CFR 882.4300
Advisory panel: Neurology
Date received: 2016-01-20
Decision date: 2016-03-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, 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.