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, Prescription
510(k) Number K213424
Device Name Jabra Enhance Plus
Applicant
GN Hearing A/S
Lautrupbjerg 7
Ballerup,  DK DK-2750
Applicant Contact Lars Hagander
Correspondent
GN Hearing A/S
Lautrupbjerg 7
Ballerup,  DK DK-2750
Correspondent Contact Lars Hagander
Regulation Number874.3325
Classification Product Code
QDD  
Subsequent Product Code
QUH  
Date Received10/21/2021
Decision Date 01/19/2022
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
-
-