510(k) K042223

XLTEK CONNEX IP HEADBOX, MODEL 1054 by Excel Tech. , Ltd. — Product Code OMB

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 16, 2004
Date Received: August 17, 2004
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Automatic Event Detection Software For Full-Montage Electroencephalograph
Device Class: Class II
Regulation Number: 882.1400
Review Panel: NE
Submission Type

Automatically mark or identify electroencephalograph waveforms for spikes, electrographic seizures, seizure-like events in order to aid in identification of such events and help review and annotation of prolonged EEG traces; All output subject to verification by qualified user

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K042150 — XLTEK TREX MODEL#10309 (August 27, 2004)
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K040360 — EMU128S, MODEL EX-NW-128S (March 12, 2004)
K022037 — XLTEK SLEEP SYSTEM (September 10, 2002)

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