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510(k) K242954

Integrity V500 (Integrity, Integrity with VEMP) by Vivosonic, Inc. — Product Code GWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2024
Date Received
September 25, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Auditory, Evoked Response
Device Class
Class II
Regulation Number
882.1900
Review Panel
NE
Submission Type

Other clearances by Vivosonic, Inc.

  • 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)
  • K003364 — VIVO 200 DPS VIVOSCAN (July 18, 2001)

Other clearances for product code GWJ

  • K233649 — ALGO Pro Newborn Hearing Screener (ALGO Pro) (March 8, 2024)
  • K220139 — QScreen (August 3, 2022)
  • K211147 — ALGO 7i (October 14, 2021)
  • K193033 — GSI Audera Pro (April 24, 2020)
  • K163326 — SmartEP (September 29, 2017)
  • K162037 — Eclipse with VEMP (March 23, 2017)
  • K143670 — ICS CHARTR EP 200 WITH VEMP (October 23, 2015)
  • K141446 — ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO H (August 22, 2014)
  • K132957 — MADSEN ACCUSCREEN TYPE 1077 (February 27, 2014)
  • K131141 — EARPROBE (June 27, 2013)