510(k) K021599

96 CHANNEL EEG HEADBOX MODEL EMU96 by Excel Tech. , Ltd. — Product Code GWQ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 13, 2002
Date Received: May 15, 2002
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Full-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 full montage array (i.e., 16 or more electrodes) and user-specified locations

Other clearances by Excel Tech. , Ltd.

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K053386 — XLTEK EMU40 EEG HEADBOX, MODEL PK1072 (April 21, 2006)
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K042223 — XLTEK CONNEX IP HEADBOX, MODEL 1054 (September 16, 2004)
K042150 — XLTEK TREX MODEL#10309 (August 27, 2004)
K040358 — XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248 (August 6, 2004)
K040360 — EMU128S, MODEL EX-NW-128S (March 12, 2004)

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