FDA 510(k) Application Details - K083667

Device Classification Name	Transducer, Ultrasonic, Diagnostic   More FDA Info for this Device
510(K) Number	K083667
Device Name	Transducer, Ultrasonic, Diagnostic
Applicant	B-K MEDICAL APS MILEPARKEN 34 HERLEV DK-2730 DK Other 510(k) Applications for this Company
Contact	LARS OKSBY HANSEN Other 510(k) Applications for this Contact
Regulation Number	892.1570   More FDA Info for this Regulation Number
Classification Product Code	ITX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/11/2008
Decision Date	02/02/2009
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