FDA 510(k) Application Details - K090386

Device Classification Name Thermometer, Electronic, Clinical

  More FDA Info for this Device
510(K) Number K090386
Device Name Thermometer, Electronic, Clinical
Applicant MEDISIM LTD.
G.G. COMMUNICATIONS CENTER
NEVE ILAN 90850 IL
Other 510(k) Applications for this Company
Contact YEVGENIA LIBSTER
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 02/17/2009
Decision Date 05/28/2010
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