NEUROLINK IP MODEL: PK1117— 510(k) K100683

Name: FDA 510(k) clearance K100683
Creator: U.S. Food and Drug Administration
Published: 2010-04-09

Substantially Equivalent

Natus Medical Incorporated

FDA 510(k) clearance K100683 for NEUROLINK IP MODEL: PK1117, Substantially Equivalent on 2010-04-09. Applicant: Natus Medical Incorporated. Device class: 2.

Clearance details

Applicant: Natus Medical Incorporated
Product code: Code GWQ
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2010-03-10
Decision date: 2010-04-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Oakville, Ontario, CA

Download summary PDF View on FDA.gov ↗

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