FDA 510(k) Application Details - K112016

Device Classification Name Lamp, Infrared, Therapeutic Heating

  More FDA Info for this Device
510(K) Number K112016
Device Name Lamp, Infrared, Therapeutic Heating
Applicant YA-MAN LTD
9210 FOREST HILL AVE
STE B-3
RICHMOND, VA 23235 US
Other 510(k) Applications for this Company
Contact NELSON MARQUINA
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 07/14/2011
Decision Date 02/10/2012
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 N
Expedited Review



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