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510(k) K001467

DA VINCHI EMG/EP ISA1004EP by Airsep Corp. — Product Code GWE

K001467 is an FDA 510(k) premarket notification submitted by Airsep Corp. for the device "DA VINCHI EMG/EP ISA1004EP". The FDA issued a decision of Substantially Equivalent on August 1, 2000. The device falls under product code GWE (Stimulator, Photic, Evoked Response), a Class II device regulated under 21 CFR 882.1890. Airsep Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2000
Date Received
May 10, 2000
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 Airsep Corp.

  • K101154 — CENTROX, RELIANT, ULTROX, AS-D+, AS-E, AS-G, AS-J, AS-K AND AS-L (March 28, 2011)
  • K080348 — OXISCAN II DATA MANAGEMENT SYSTEM (October 9, 2008)
  • K020324 — LIFESTYLE OXYGEN CONCENTRATOR (March 13, 2002)
  • K012037 — HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009 (January 17, 2002)
  • K000963 — DA VINCHI EEG AND EMG/EP SYSTEMS (October 20, 2000)
  • K001579 — IMPULSE SELECT (August 31, 2000)
  • K001013 — MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY (May 16, 2000)
  • K992283 — ARTISAN ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY (August 27, 1999)
  • K983002 — MYSTIQUE ULTRASONIC NEBULIZER (October 16, 1998)
  • K960309 — AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTRATOR (MODIFICATION) (February 28, 1997)

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