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510(k) K033108

VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER by Vivosonic, Inc. — Product Code EWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2003
Date Received
September 30, 2003
Clearance Type
Special
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.

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  • K080060 — VIVOSONIC NEUROSCREEN (April 4, 2008)
  • K043396 — INTEGRITY, MODEL V500 (January 24, 2005)
  • K003364 — VIVO 200 DPS VIVOSCAN (July 18, 2001)

Other clearances for product code EWO

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  • 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)