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 K913356
Device Name THE MONITOR/DEMLAR MODEL MI-5000 AUDIOMETER
Applicant
MONITOR INSTRUMENTS, INC.
605 EASTOWNE DR.
CHAPEL HILL,  NC  27514
Applicant Contact MACK J PRESLAR
Correspondent
MONITOR INSTRUMENTS, INC.
605 EASTOWNE DR.
CHAPEL HILL,  NC  27514
Correspondent Contact MACK J PRESLAR
Regulation Number874.1050
Classification Product Code
EWO  
Date Received07/30/1991
Decision Date 12/05/1991
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
-
-