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510(k) K233649

ALGO Pro Newborn Hearing Screener (ALGO Pro) by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) — Product Code GWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 2024
Date Received
November 14, 2023
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 Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

  • K242930 — Natus BrainWatch System (November 19, 2024)
  • K203500 — RetCam Envision (April 13, 2021)
  • K200878 — Natus NeuroWorks (May 18, 2020)
  • K173936 — Natus Photic Stimulator (June 15, 2018)
  • K180290 — Natus Brain Monitor Amplifier (June 14, 2018)
  • K180421 — Natus NeuroWorks (March 14, 2018)
  • K173690 — Grass TWin (March 9, 2018)
  • K172711 — Comet-PLUS (November 3, 2017)
  • K163163 — XLTEK EMU40EX EEG Headbox (December 14, 2016)
  • K162595 — Trex_HD (November 4, 2016)

Other clearances for product code GWJ

  • K242954 — Integrity V500 (Integrity, Integrity with VEMP) (December 19, 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)