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510(k) K934715

MODEL 222 CLINICAL AUDIOMETER by Virtual Corp. — Product Code EWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 1994
Date Received
October 1, 1993
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 Virtual Corp.

  • K960500 — THE VIRTUAL M-332 (April 3, 1996)
  • K930203 — MODEL 322 CLINICAL AUDIOMETER (July 8, 1993)
  • K926574 — MODEL 330 SCREENING AUDIO METER, MODIFIED (March 29, 1993)
  • K911689 — MODEL 330 SCREENING AUDIOMETER (October 21, 1991)
  • K895443 — MODEL 210 IMPEDANCE SYSTEM (January 16, 1990)
  • K896301 — MODEL 340 PROBE MIC SYSTEM (January 16, 1990)
  • K863984 — MODEL 320 TWO CHANNEL AUDIOMETER (November 18, 1986)
  • K853863 — MODEL 310 IMPEDANCE SYSTEM (December 18, 1985)

Other clearances for product code EWO

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  • 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)