FDA 510(k) Application Details - K003041

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K003041
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	B-K MEDICAL A/S SANDTOFTEN 9 GENTOFTE DK-2820 DK Other 510(k) Applications for this Company
Contact	VILLY BRAENDER Other 510(k) Applications for this Contact
Regulation Number	892.1560   More FDA Info for this Regulation Number
Classification Product Code	IYO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2000
Decision Date	02/07/2001
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