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 Masker, Tinnitus
510(k) Number K130514
Device Name AUDIFON ARRIVA CIC, IS, IS+, M, S, S+, X TRT, AUDIFON VICO, AUDIFON PRADO, AUDIFON ELIA, CIC, IS, IS+, M, S TRT
Applicant
AUDIFON-USA INC.
403 CHAIRMAN COURT, STE. 1
DEBARY,  FL  32713
Applicant Contact JANE E PERRONE
Correspondent
AUDIFON-USA INC.
403 CHAIRMAN COURT, STE. 1
DEBARY,  FL  32713
Correspondent Contact JANE E PERRONE
Regulation Number874.3400
Classification Product Code
KLW  
Subsequent Product Code
ESD  
Date Received02/27/2013
Decision Date 11/21/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
-
-