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 audiometer
510(k) Number K981327
Device Name INTERACOUSTICS MODEL AD226 DIAGNOSTIC AUDIOMETER
Applicant
IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE)
4814 EAST SECOND ST.
BENICIA,  CA  94510
Applicant Contact DONNA WARD
Correspondent
IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE)
4814 EAST SECOND ST.
BENICIA,  CA  94510
Correspondent Contact DONNA WARD
Regulation Number874.1050
Classification Product Code
EWO  
Date Received04/13/1998
Decision Date 05/11/1998
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
-
-