FDA 510(k) Application Details - K992473

Device Classification Name Nystagmograph

  More FDA Info for this Device
510(K) Number K992473
Device Name Nystagmograph
Applicant OPTOMOTOR LABORATORIES
TIVOLISTR. 11
D-79104 FREIBURG D-79104 DE
Other 510(k) Applications for this Company
Contact BURKHART FISCHER
Other 510(k) Applications for this Contact
Regulation Number 882.1460

  More FDA Info for this Regulation Number
Classification Product Code GWN
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 07/26/1999
Decision Date 08/12/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact