NEUROPORT CORTICAL MICROELECTRODE ARRAY SYSTEM— 510(k) K110010

Name: FDA 510(k) clearance K110010
Creator: U.S. Food and Drug Administration
Published: 2011-02-09

Substantially Equivalent

Blackrock Microsystems, Inc.

FDA 510(k) clearance K110010 for NEUROPORT CORTICAL MICROELECTRODE ARRAY SYSTEM, Substantially Equivalent on 2011-02-09. Applicant: Blackrock Microsystems, Inc.. Device class: 2.

Clearance details

Applicant: Blackrock Microsystems, Inc.
Product code: Code GZL
Device class: Class 2
Regulation: 21 CFR 882.1330
Advisory panel: Neurology
Date received: 2011-01-03
Decision date: 2011-02-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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