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 Apparatus, Vestibular Analysis
510(k) Number K102364
Device Name NYDIAG 200
Applicant
Interacoustics A/S
Drejervaenget 8
Assens,  DK DK-5610
Applicant Contact ERIK NIELSEN
Correspondent
Interacoustics A/S
Drejervaenget 8
Assens,  DK DK-5610
Correspondent Contact ERIK NIELSEN
Classification Product Code
LXV  
Date Received08/20/2010
Decision Date 12/23/2010
Decision Substantially Equivalent (SESE)
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-