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 K053216
Device Name HEARID WIDEBAND MIDDLE EAR POWER ANALYZER
Applicant
MIMOSA ACOUSTICS, INC.
60 HAZELWOOD DR., SUITE #209
CHAMPAIGN,  IL  61820
Applicant Contact PATRICIA S JENG
Correspondent
MIMOSA ACOUSTICS, INC.
60 HAZELWOOD DR., SUITE #209
CHAMPAIGN,  IL  61820
Correspondent Contact PATRICIA S JENG
Regulation Number874.1050
Classification Product Code
EWO  
Subsequent Product Code
GWJ  
Date Received11/17/2005
Decision Date 02/10/2006
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
-
-