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510(k) K003364

VIVO 200 DPS VIVOSCAN by Vivosonic, Inc. — Product Code EWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2001
Date Received
October 27, 2000
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 Vivosonic, Inc.

  • K242954 — Integrity V500 (Integrity, Integrity with VEMP) (December 19, 2024)
  • K080060 — VIVOSONIC NEUROSCREEN (April 4, 2008)
  • K043396 — INTEGRITY, MODEL V500 (January 24, 2005)
  • K033108 — VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER (October 27, 2003)

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)