Home / 510(k) Clearances / K220139

510(k) K220139

QScreen by Path Medical GmbH — Product Code GWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 2022
Date Received
January 18, 2022
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 Path Medical GmbH

  • K213345 — Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, Na (June 22, 2022)
  • K211147 — ALGO 7i (October 14, 2021)
  • K133012 — SENTIERO (June 9, 2014)
  • K131141 — EARPROBE (June 27, 2013)
  • K100661 — EARPROBE (July 1, 2010)

Other clearances for product code GWJ

  • K242954 — Integrity V500 (Integrity, Integrity with VEMP) (December 19, 2024)
  • K233649 — ALGO Pro Newborn Hearing Screener (ALGO Pro) (March 8, 2024)
  • 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)