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 K901745
Device Name AUDIOTONE MODEL A-52S BEHIND-THE-EAR HEARING INST.
Applicant
MIRACLE-EAR, INC.
600 SOUTH COUNTY RD. 18
MINNEAPOLIS,  MN  55426
Applicant Contact KEVIN KUTINA
Correspondent
MIRACLE-EAR, INC.
600 SOUTH COUNTY RD. 18
MINNEAPOLIS,  MN  55426
Correspondent Contact KEVIN KUTINA
Regulation Number874.3300
Classification Product Code
ESD  
Date Received04/17/1990
Decision Date 05/29/1990
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
-
-