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 hearing aid, air-conduction, prescription
510(k) Number K961059
Device Name DIGIFOCUS COMPACT
Applicant
OTICON, INC.
29 SCHOOLHOUSE RD.
SOMERSET,  NJ  08873
Applicant Contact PREBEN BRUNVED
Correspondent
OTICON, INC.
29 SCHOOLHOUSE RD.
SOMERSET,  NJ  08873
Correspondent Contact PREBEN BRUNVED
Regulation Number874.3300
Classification Product Code
ESD  
Date Received03/18/1996
Decision Date 05/07/1996
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
-
-