• 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 K954936
Device Name BELTONE ULTIMA 80 OTOSONIC POWER PAS
Applicant
BELTONE ELECTRONICS CORP.
4201 WEST VICTORIA ST.
CHICAGO,  IL  60646
Applicant Contact ROBERT A KRATOCHVILKK
Correspondent
BELTONE ELECTRONICS CORP.
4201 WEST VICTORIA ST.
CHICAGO,  IL  60646
Correspondent Contact ROBERT A KRATOCHVILKK
Regulation Number874.3300
Classification Product Code
ESD  
Date Received10/27/1995
Decision Date 12/06/1995
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
-
-