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510(k) K112733

ER35 ERO-SCAN PRO HEARING TEST SYSTEM by Etymotic Research, Inc. — Product Code EWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2011
Date Received
September 20, 2011
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 Etymotic Research, Inc.

  • K150491 — ER36 Series OAE Test System (March 26, 2015)
  • K070880 — ER35 ERO-SCAN PRO HEARING TEST SYSTEM (June 7, 2007)
  • K011114 — ETYMOTIC RESEARCH ER-10D OAE PROBE (July 3, 2001)
  • K010165 — ERO SCAN OAE TEST SYSTEM (March 12, 2001)
  • K980533 — ERO-SCAN OTOACOUSTIC EMISSIONS TEST INST. (ER34) (March 23, 1998)
  • K930553 — CUB DIS OTOACOUSTIC EMISSIONS TEST INSTRUMENT (September 29, 1993)
  • K930003 — TUBEPHONE MODELS ER-3A & ER-3 INSERT EARPHONES (June 18, 1993)
  • K873298 — ELEC-TIP (November 24, 1987)
  • K861113 — ER-7C CLINICAL PROBE MICROPHONE (April 23, 1986)
  • K843144 — K-BASS LO FREQUENCY HEARING AID (September 7, 1984)

Other clearances for product code EWO

  • K234095 — OtoNova/OtoNova Pro (June 21, 2024)
  • K240430 — Otoport Pro (March 15, 2024)
  • K231545 — hearOAE (October 27, 2023)
  • K213345 — Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, Na (June 22, 2022)
  • 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)