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 K853381
Device Name OE SERIES OF BEHIND-THE-EAR HEARING AIDS
Applicant
EMTECH LABORATORIES
P.O. BOX 12900
ROANOKE,  VA  24022
Applicant Contact JERRY AGNEW
Correspondent
EMTECH LABORATORIES
P.O. BOX 12900
ROANOKE,  VA  24022
Correspondent Contact JERRY AGNEW
Regulation Number874.3300
Classification Product Code
ESD  
Date Received08/12/1985
Decision Date 11/08/1985
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
-
-