• 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 K943616
Device Name BELTONE PERSONAL HEARING SCREENER
Applicant
BELTONE ELECTRONICS CORP.
4201 WEST VICTORIA ST.
CHICAGO,  IL  60646
Applicant Contact ROBERT A KRATOCHVIL
Correspondent
BELTONE ELECTRONICS CORP.
4201 WEST VICTORIA ST.
CHICAGO,  IL  60646
Correspondent Contact ROBERT A KRATOCHVIL
Regulation Number874.1050
Classification Product Code
EWO  
Date Received07/27/1994
Decision Date 07/12/1995
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
-
-