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 Nystagmograph
510(k) Number K982103
Device Name ULMER (VNG) VIDEO NYSTAGMOGRAPH
Applicant
SYNAPSYS, INC.
1400 MAIN ST.
LOUISVILLE,  CO  80027
Applicant Contact VERA BUFFALOE
Correspondent
SYNAPSYS, INC.
1400 MAIN ST.
LOUISVILLE,  CO  80027
Correspondent Contact VERA BUFFALOE
Regulation Number882.1460
Classification Product Code
GWN  
Date Received06/15/1998
Decision Date 09/11/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-