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 Self-Fitting Air-Conduction Hearing Aid, Over The Counter
510(k) Number K231550
Device Name Sontro® OTC Hearing Aids (AI)
Applicant
Soundwave Hearing, LLC
619 Enterprise Dr.
Suite #205
Oak Brook,  IL  60253
Applicant Contact Anthony Florek
Correspondent
Rook Quality Systems, Inc.
1155 Mount Vernon Hwy., Suite 800
Dunwoody,  GA  30338
Correspondent Contact Kyle Rose
Regulation Number874.3325
Classification Product Code
QUH  
Date Received05/30/2023
Decision Date 10/26/2023
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
Predetermined Change
Control Plan Authorized		 No
-
-