FDA 510(k) Application Details - K102529

Device Classification Name	More FDA Info for this Device
510(K) Number	K102529
Device Name	D2RF DIGITAL DYNAMIC REMOTE SYSTEM
Applicant	STEPHANIX RADIOLOGICAL SYSTEMS 8870 RAVELLO COURT NAPLES, FL 34114 US Other 510(k) Applications for this Company
Contact	DANIEL KAMM Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/02/2010
Decision Date	10/07/2010
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