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510(k) K991903

EXCEL PHOTIC STIMULATOR, MODEL (XLPS-1) by Excel Tech. , Ltd. — Product Code GWE

K991903 is an FDA 510(k) premarket notification submitted by Excel Tech. , Ltd. for the device "EXCEL PHOTIC STIMULATOR, MODEL (XLPS-1)". The FDA issued a decision of Substantially Equivalent on August 4, 1999. The device falls under product code GWE (Stimulator, Photic, Evoked Response), a Class II device regulated under 21 CFR 882.1890. Excel Tech. , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1999
Date Received
June 4, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Photic, Evoked Response
Device Class
Class II
Regulation Number
882.1890
Review Panel
NE
Submission Type

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 GWE

  • K221471 — E3 and Profile (November 22, 2022)
  • K212936 — Vision Monitor- MonCvONE (November 21, 2022)
  • K211974 — LED PHOTIC System (September 23, 2021)
  • K211643 — Vision Monitor - MonpackONE (July 26, 2021)
  • K200705 — Nurochek System (April 23, 2020)
  • K173936 — Natus Photic Stimulator (June 15, 2018)
  • K142567 — RETeval Visual Electrodiagnostic Device (May 19, 2015)
  • K113785 — ADHERENT VISUAL STIMULATOR GOGGLES (June 6, 2012)
  • K120104 — VISIONSEARCH 1 (May 21, 2012)
  • K101763 — DIOPSYS NOVA VEP VISION TESTING SYSTEM (May 9, 2011)

FDA data resources