FDA 510(k) Application Details - K991937

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K991937
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	B & K MEDICAL A/S SANDTOFTEN 9 DK 2820 GENTOFTE 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	06/09/1999
Decision Date	07/30/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review