510(k) K053386

XLTEK EMU40 EEG HEADBOX, MODEL PK1072 by Excel Tech. , Ltd. — Product Code GWQ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 21, 2006
Date Received: December 5, 2005
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.

K062549 — XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 10523 (October 4, 2006)
K061269 — XLTEK CLEAN SIGNAL ADHESIVE ELECTRODES (August 14, 2006)
K053058 — XLTEK NEUROPATH, MODEL PK1070 (February 7, 2006)
K052112 — XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059 (October 28, 2005)
K052111 — XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382 (August 17, 2005)
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)
K022037 — XLTEK SLEEP SYSTEM (September 10, 2002)

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