FDA 510(k) Application Details - K100563

Device Classification Name Thermometer, Electronic, Clinical

  More FDA Info for this Device
510(K) Number K100563
Device Name Thermometer, Electronic, Clinical
Applicant GEON CORPORATION
2904 N. BOLDT DRIVE
FLAGSTAFF, AZ 86001 US
Other 510(k) Applications for this Company
Contact JENNIFER REICH
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 03/01/2010
Decision Date 06/02/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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