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510(k) K173567

Sera by Interacoustics A/S — Product Code EWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2018
Date Received
November 20, 2017
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 Interacoustics A/S

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  • K192652 — TRV (May 27, 2020)
  • K191372 — Lyra (July 15, 2019)
  • K163149 — VisualEyes (April 26, 2017)
  • K162037 — Eclipse with VEMP (March 23, 2017)
  • K152112 — VisualEyes (December 29, 2015)
  • K151616 — AT235 (July 15, 2015)
  • K131681 — EYESEECAM VHIT (September 6, 2013)
  • K130795 — TITAN (June 20, 2013)

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)
  • K172403 — GSI Novus (October 20, 2017)
  • K171506 — Easyscreen (August 29, 2017)
  • K151025 — iHearTest (December 29, 2015)
  • K150491 — ER36 Series OAE Test System (March 26, 2015)