FDA 510(k) Application Details - K141154

Device Classification Name	Dosimeter, Ionizing Radiation, Implanted   More FDA Info for this Device
510(K) Number	K141154
Device Name	Dosimeter, Ionizing Radiation, Implanted
Applicant	RADIADYNE 816 CONGRESS AVE. SUITE 1400 AUSTIN, TX 78701 US Other 510(k) Applications for this Company
Contact	STUART R GOLDMAN Other 510(k) Applications for this Contact
Regulation Number	892.5050   More FDA Info for this Regulation Number
Classification Product Code	NZT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/05/2014
Decision Date	07/22/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review