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 K994033
Device Name HORTMANN ECHOMASTER OAE ANALYZER
Applicant
Hortmann AG
P.O. Box 1119
Dripping Springs,  TX  78620
Applicant Contact BRADFORD MELANCON
Correspondent
Hortmann AG
P.O. Box 1119
Dripping Springs,  TX  78620
Correspondent Contact BRADFORD MELANCON
Regulation Number874.1050
Classification Product Code
EWO  
Date Received11/26/1999
Decision Date 02/24/2000
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
Predetermined Change
Control Plan Authorized		 No
-
-