NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM— 510(k) K042384

Name: FDA 510(k) clearance K042384
Creator: U.S. Food and Drug Administration
Published: 2005-03-29

Substantially Equivalent

Cyberkinetics, Inc. (Cki)

FDA 510(k) clearance K042384 for NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM, Substantially Equivalent on 2005-03-29. Applicant: Cyberkinetics, Inc. (Cki). Device class: 2.

Clearance details

Applicant: Cyberkinetics, Inc. (Cki)
Product code: Code GZL
Device class: Class 2
Regulation: 21 CFR 882.1330
Advisory panel: Neurology
Date received: 2004-09-01
Decision date: 2005-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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