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 Tester, Auditory Impedance
510(k) Number K905704
Device Name MA630 IMPED SCREENER/MA640 IMPED/AUDIOMET SCREENER
Applicant
MAICO HEARING INSTRUMENTS, INC.
7375 BUSH LAKE RD.
MINNEAPOLIS,  MN  55439 -2029
Applicant Contact LOIS DONNAY
Correspondent
MAICO HEARING INSTRUMENTS, INC.
7375 BUSH LAKE RD.
MINNEAPOLIS,  MN  55439 -2029
Correspondent Contact LOIS DONNAY
Regulation Number874.1090
Classification Product Code
ETY  
Date Received12/21/1990
Decision Date 04/30/1991
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
-
-