FDA 510(k) Application Details - K083560

Device Classification Name Lamp, Infrared, Therapeutic Heating

  More FDA Info for this Device
510(K) Number K083560
Device Name Lamp, Infrared, Therapeutic Heating
Applicant LIGHTHOUSE TECHNICAL INNOVATIONS, INC.
1705 S. CAPITAL OF TEXAS HWY.
SUITE 500
AUSTIN, TX 78746 US
Other 510(k) Applications for this Company
Contact JEAN ASQUITH
Other 510(k) Applications for this Contact
Regulation Number 890.5500

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

  More FDA Info for this Product Code
Date Received 12/02/2008
Decision Date 12/11/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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