FDA 510(K) K042384, EUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM
FDA 510(K) K042384, EUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM
Device Classification Name Electrode, Depth
510(k) Number K042384
Device Name NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM
Applicant CYBERKINETICS, INC. (CKI)
Regulation Number 882.1330
Classification Product Code GZL
Subsequent Product Code GWL
Date Received 09/01/2004
Decision Date 03/29/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
Total pages: 618
Fully redacted pages: 383
Content pages: 235
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