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510(k) K042223

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

K042223 is an FDA 510(k) premarket notification submitted by Excel Tech. , Ltd. for the device "XLTEK CONNEX IP HEADBOX, MODEL 1054". The FDA issued a decision of Substantially Equivalent on September 16, 2004. The device falls under product code OMB (Automatic Event Detection Software For Full-Montage Electroencephalograph), a Class II device regulated under 21 CFR 882.1400. Excel Tech. , Ltd. has at least 10 other 510(k) clearances on record.

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

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)
  • K053386 — XLTEK EMU40 EEG HEADBOX, MODEL PK1072 (April 21, 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)
  • 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)

Other clearances for product code OMB

  • K260998 — Ceribell Neurology Review Software (June 24, 2026)
  • K252070 — Ceribell Infant Seizure Detection Software (November 21, 2025)
  • K252160 — Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) (October 31, 2025)
  • K243743 — autoSCORE (V 2.0.0) (April 9, 2025)
  • K241589 — Ceribell Seizure Detection Software (April 9, 2025)
  • K242446 — Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) (January 22, 2025)
  • K241390 — NeuroMatch (November 26, 2024)
  • K240408 — REMI-AI Rapid Detection Module (REMI-AI RDM) (October 17, 2024)
  • K240993 — encevis (2.1) (September 27, 2024)
  • K231068 — autoSCORE (January 7, 2024)

FDA data resources