FDA 510(k) Application Details - K120282

Device Classification Name	More FDA Info for this Device
510(K) Number	K120282
Device Name	CARDNAV
Applicant	PAIEON, INC. 23 HAMELACHA ST., P.O.B. 11355 ROSH HAAYIN 48901 IL Other 510(k) Applications for this Company
Contact	SHIMON VAKNIN 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	01/31/2012
Decision Date	12/10/2012
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