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 K914796
Device Name PREMIER ASP/CD RECHARGEABLE
Applicant
ELECTONE, INC.
1124 FLORIDA CENTRAL PKWY.
LONGWOOD,  FL  32750
Applicant Contact JIM NEE
Correspondent
ELECTONE, INC.
1124 FLORIDA CENTRAL PKWY.
LONGWOOD,  FL  32750
Correspondent Contact JIM NEE
Regulation Number874.3300
Classification Product Code
ESD  
Date Received10/23/1991
Decision Date 02/18/1992
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
-
-