• 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 hearing aid, air-conduction, prescription
510(k) Number K942830
Device Name HAE 3
Applicant
HEARING AID EXPRESS
5137 BELLAIRE
BELLAIRE,  TX  77401
Applicant Contact MARK BRUMBACK
Correspondent
HEARING AID EXPRESS
5137 BELLAIRE
BELLAIRE,  TX  77401
Correspondent Contact MARK BRUMBACK
Regulation Number874.3300
Classification Product Code
ESD  
Date Received06/14/1994
Decision Date 07/20/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-