• 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 K913221
Device Name TYPE FA10 AUDIOMETER
Applicant
FRYE ELECTRONICS, INC.
P.O. BOX 23391
9826 S.W. TIGARD ST.
TIGARD,  OR  97223
Applicant Contact GEORGE J FRYE
Correspondent
FRYE ELECTRONICS, INC.
P.O. BOX 23391
9826 S.W. TIGARD ST.
TIGARD,  OR  97223
Correspondent Contact GEORGE J FRYE
Regulation Number874.1050
Classification Product Code
EWO  
Date Received07/19/1991
Decision Date 10/11/1991
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
-
-