• 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 K854835
Device Name DAHLBERG MODEL GF MICROPROCESSOR AUDIOMETER
Applicant
MIRACLE-EAR/DAHLBERG, INC.
7731 COUNTRY CLUB DR.
GOLDEN VALLEY,  MN  55427
Applicant Contact JANE E HIXSON
Correspondent
MIRACLE-EAR/DAHLBERG, INC.
7731 COUNTRY CLUB DR.
GOLDEN VALLEY,  MN  55427
Correspondent Contact JANE E HIXSON
Regulation Number874.1050
Classification Product Code
EWO  
Date Received12/03/1985
Decision Date 03/04/1986
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
-
-