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 K844985
Device Name IN THE EAR MODEL X-ITE 84
Applicant
BERNAFON, INC.
1125 GLOBE AVE.
P.O. BOX 1160
MOUNTAINSIDE,  NJ  07092
Applicant Contact TED MIKSIEWICA
Correspondent
BERNAFON, INC.
1125 GLOBE AVE.
P.O. BOX 1160
MOUNTAINSIDE,  NJ  07092
Correspondent Contact TED MIKSIEWICA
Regulation Number874.3300
Classification Product Code
ESD  
Date Received12/26/1984
Decision Date 01/23/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-