FDA 510(k) Application Details - K042529

Device Classification Name Nystagmograph

  More FDA Info for this Device
510(K) Number K042529
Device Name Nystagmograph
Applicant FALL PREVENTION TECHNOLOGIES, LLC
2300 NW CORPORATE BLVD.
SUITE 141
BOCA RATON, FL 33431 US
Other 510(k) Applications for this Company
Contact KEITH KRAVITZ
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 09/17/2004
Decision Date 10/06/2004
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 Y
Expedited Review



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