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 K963878
Device Name AHS OMEGA HF
Applicant
Authorized Hearing Systems, Inc.
806 Beaver St.
Bristol,  PA  19007
Applicant Contact HENRY SMITH
Correspondent
Authorized Hearing Systems, Inc.
806 Beaver St.
Bristol,  PA  19007
Correspondent Contact HENRY SMITH
Regulation Number874.3300
Classification Product Code
ESD  
Date Received09/26/1996
Decision Date 12/06/1996
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
Predetermined Change
Control Plan Authorized		 No
-
-