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 K103298
Device Name ACAM 5 AUDIOMETER SYSTEM
Applicant
ACOUSTICON GMBH
1983 Hazelwood Road
TOMS RIVER,  NJ  08754
Applicant Contact Maureen Garner
Correspondent
ACOUSTICON GMBH
1983 Hazelwood Road
TOMS RIVER,  NJ  08754
Correspondent Contact Maureen Garner
Regulation Number874.1050
Classification Product Code
EWO  
Date Received11/08/2010
Decision Date 04/08/2011
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
-
-