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510(k) K060523

NEUROPORT NEURAL SIGNAL PROCESSING SYSTEM by Cyberkinetics, Inc. — Product Code OMC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2006
Date Received
February 27, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reduced- Montage Standard Electroencephalograph
Device Class
Class II
Regulation Number
882.1400
Review Panel
NE
Submission Type

Acquire, display, store, and archive electroencephalographic signals from the brain using a user-specified and/or sponsor-specified locations with a reduced array (i.e. less than < 16) of electrodes

Other clearances by Cyberkinetics, Inc.

  • K042626 — NEUROPORT NEURAL SIGNAL PROCESSOR (NSP) SYSTEM (March 28, 2005)

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