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 audiometer
510(k) Number K981142
Device Name MAICO MA53
Applicant
BERNAFON-MAICO, INC.
9675 WEST 76TH ST.
EDEN PRAIRIE,  MN  55344
Applicant Contact SCOTT SAVRE
Correspondent
BERNAFON-MAICO, INC.
9675 WEST 76TH ST.
EDEN PRAIRIE,  MN  55344
Correspondent Contact SCOTT SAVRE
Regulation Number874.1050
Classification Product Code
EWO  
Date Received03/30/1998
Decision Date 04/22/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-