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510(k) K122496

AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM by Bio-Logic Systems Corp. — Product Code EWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 2012
Date Received
August 16, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Audiometer
Device Class
Class II
Regulation Number
874.1050
Review Panel
EN
Submission Type

Other clearances by Bio-Logic Systems Corp.

  • 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)
  • K031009 — MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL (EP) SYSTEM (April 28, 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 EWO

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  • K191372 — Lyra (July 15, 2019)
  • K180287 — GSI Corti (May 11, 2018)
  • K173567 — Sera (February 14, 2018)
  • K172403 — GSI Novus (October 20, 2017)
  • K171506 — Easyscreen (August 29, 2017)
  • K151025 — iHearTest (December 29, 2015)