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 K150491
Device Name ER36 Series OAE Test System
Applicant
Etymotic Research, Inc.
61 Martin Ln.
Elk Grove Village,  IL  60007
Applicant Contact Steve Iseberg
Correspondent
Nsf Health Sciences Medical Devices
2001 Pennsylvania Ave. NW, Suite 950
Washington,  DC  20006
Correspondent Contact Meaghan Bailey
Regulation Number874.1050
Classification Product Code
EWO  
Date Received02/25/2015
Decision Date 03/26/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-