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510(k) K022037

XLTEK SLEEP SYSTEM by Excel Tech. , Ltd. — Product Code OLV

K022037 is an FDA 510(k) premarket notification submitted by Excel Tech. , Ltd. for the device "XLTEK SLEEP SYSTEM". The FDA issued a decision of Substantially Equivalent on September 10, 2002. The device falls under product code OLV (Standard Polysomnograph With 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 10, 2002
Date Received
June 24, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Standard Polysomnograph With Electroencephalograph
Device Class
Class II
Regulation Number
882.1400
Review Panel
NE
Submission Type

Acquire, display, store, and archive electroencephalographic signals from the brain and other signals (such as electromyography, respiratory and/or oximetry signals) for sleep recordings. May also be used to allow on-screen review, user-controlled annotation and user-controlled marking of data.

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)
  • 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)

Other clearances for product code OLV

  • K260585 — Noxturnal Web (March 20, 2026)
  • K242447 — Falcon HST (February 20, 2025)
  • K241288 — Noxturnal Web (December 23, 2024)
  • K240700 — HomeSleepTest (HST, HST REM+) (December 8, 2024)
  • K213007 — Cerebra Sleep System (July 6, 2022)
  • K201054 — SOMNOscreen plus (August 12, 2020)
  • K192624 — ApneaTrak (February 20, 2020)
  • K181709 — Serenity Piezo Sensor, Serenity Thermocouple Sensor (November 16, 2018)
  • K173868 — Serenity Body Position Sensor, Serenity RIP Sensors (July 2, 2018)
  • K173690 — Grass TWin (March 9, 2018)

FDA data resources