CERVELLO BIO-POTENTIAL SIGNAL ACQUISTION SYSTEM PRODUCT FAMILY— 510(k) K122196

Name: FDA 510(k) clearance K122196
Creator: U.S. Food and Drug Administration
Published: 2013-05-02

Substantially Equivalent

Blackrock Neuromed, LLC

FDA 510(k) clearance K122196 for CERVELLO BIO-POTENTIAL SIGNAL ACQUISTION SYSTEM PRODUCT FAMILY, Substantially Equivalent on 2013-05-02. Applicant: Blackrock Neuromed, LLC. Device class: 2.

Clearance details

Applicant: Blackrock Neuromed, LLC
Product code: Code GWQ
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2012-07-24
Decision date: 2013-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oconomowoc, WI, US

Download summary PDF View on FDA.gov ↗

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