FDA 510(k) Application Details - K051566

Device Classification Name Thermometer, Electronic, Clinical

  More FDA Info for this Device
510(K) Number K051566
Device Name Thermometer, Electronic, Clinical
Applicant PROTON HEALTHCARE LTD.
13 RED FOX LANE
LITTLETON, CO 80127 US
Other 510(k) Applications for this Company
Contact Kevin Walls
Other 510(k) Applications for this Contact
Regulation Number 880.2910

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

  More FDA Info for this Product Code
Date Received 06/14/2005
Decision Date 01/17/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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