Home / 510(k) Clearances / K031009

510(k) K031009

MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL (EP) SYSTEM by Bio-Logic Systems Corp. — Product Code GWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 2003
Date Received
March 31, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Auditory, Evoked Response
Device Class
Class II
Regulation Number
882.1900
Review Panel
NE
Submission Type

Other clearances by Bio-Logic Systems Corp.

  • K122496 — AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM (November 1, 2012)
  • K121512 — SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM (July 26, 2012)
  • K073626 — BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM (February 5, 2008)
  • K061744 — COCHLEA-SCAN / COCHLEA-SCAN PLUS (September 15, 2006)
  • K052066 — CEEGRAPH/SLEEPSCAN NETLINK TRAVELER (August 26, 2005)
  • K031352 — BIO-LOGIC INSERT EARPHONES (July 16, 2003)
  • K030907 — STACKED ABR FOR NAVIGATOR PRO (May 9, 2003)
  • K021895 — BIO-LOGIC MASTER EVOKED RESPONSE SYSTEM (July 1, 2002)
  • K021801 — BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS (June 27, 2002)
  • K021215 — BIO-LOGIC ABAER CUB (May 15, 2002)

Other clearances for product code GWJ

  • K242954 — Integrity V500 (Integrity, Integrity with VEMP) (December 19, 2024)
  • K233649 — ALGO Pro Newborn Hearing Screener (ALGO Pro) (March 8, 2024)
  • K220139 — QScreen (August 3, 2022)
  • K211147 — ALGO 7i (October 14, 2021)
  • K193033 — GSI Audera Pro (April 24, 2020)
  • K163326 — SmartEP (September 29, 2017)
  • K162037 — Eclipse with VEMP (March 23, 2017)
  • K143670 — ICS CHARTR EP 200 WITH VEMP (October 23, 2015)
  • K141446 — ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO H (August 22, 2014)
  • K132957 — MADSEN ACCUSCREEN TYPE 1077 (February 27, 2014)