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510(k) K974076

SPORT/AUDX OAE TEST INSTRUMENT WITH BIO-LOGIC EAR PROBE by Bio-Logic Systems Corp. — Product Code EWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1998
Date Received
October 29, 1997
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.

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  • 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)

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