Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Audiometer
510(k) Number K231545
Device Name hearOAE
Applicant
hearX SA (Pty) Ltd
Building 2, Ashlea Gardens Office Park, 180 Garsfontein Road
Ashlea Gardens
Pretoria,  ZA 0081
Applicant Contact Seline Van Der Wat
Correspondent
hearX SA (Pty) Ltd
Building 2, Ashlea Gardens Office Park, 180 Garsfontein Road
Ashlea Gardens
Pretoria,  ZA 0081
Correspondent Contact Seline Van Der Wat
Regulation Number874.1050
Classification Product Code
EWO  
Date Received05/30/2023
Decision Date 10/27/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-