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 K111618
Device Name AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION
Applicant
Natus Medical Incorporated
388 Market St.
Suite 1460
San Francisco,  CA  94111
Applicant Contact CHARLES L MORIN
Correspondent
Natus Medical Incorporated
388 Market St.
Suite 1460
San Francisco,  CA  94111
Correspondent Contact CHARLES L MORIN
Regulation Number874.1050
Classification Product Code
EWO  
Date Received06/10/2011
Decision Date 12/28/2011
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
Predetermined Change
Control Plan Authorized		 No
-
-