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 hearing aid, air-conduction, prescription
510(k) Number K021867
Device Name INSOUND XT SERIES HEARING AID
Applicant
INSOUND MEDICAL INC.
37500 CENTRAL COURT
NEWARK,  CA  94560
Applicant Contact SUSAN WHICHARD
Correspondent
INSOUND MEDICAL INC.
37500 CENTRAL COURT
NEWARK,  CA  94560
Correspondent Contact SUSAN WHICHARD
Regulation Number874.3300
Classification Product Code
ESD  
Date Received06/06/2002
Decision Date 11/19/2002
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
-
-