Home / 510(k) Clearances / K863984

510(k) K863984

MODEL 320 TWO CHANNEL AUDIOMETER by Virtual Corp. — Product Code EWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 1986
Date Received
October 14, 1986
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)
  • K934715 — MODEL 222 CLINICAL AUDIOMETER (May 10, 1994)
  • 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)
  • K853863 — MODEL 310 IMPEDANCE SYSTEM (December 18, 1985)

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)