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510(k) K172403

GSI Novus by Grason-Stadler, Inc. — Product Code EWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 2017
Date Received
August 9, 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 Grason-Stadler, Inc.

  • K180287 — GSI Corti (May 11, 2018)
  • K000097 — GSI 2000 MIDDLE EAR ANALYZER (April 12, 2000)
  • K974237 — GSI 70 AUDIOPATH SCREENER (February 10, 1998)
  • K970324 — GSI SA60 DPOAE SYSTEM (June 6, 1997)
  • K953684 — GSI 61 CLINICAL AUDIOMETER (October 27, 1995)
  • K951759 — GSI 65 COMPUTERIZED AUDIOMETER (July 6, 1995)
  • K902540 — GSI 17 SCREENING AUDIOMETER (July 13, 1990)
  • K890124 — ILO88 OTODYNAMIC ANALYZER SCREENING AUDIOMETER (July 14, 1989)
  • K870030 — THE SCREENER GSI 55 ABR SCREENER (March 13, 1987)
  • K863353 — MIDDLE EAR ANALYZER (IMPEDANCE AUDIOMETER) (November 3, 1986)

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