FDA 510(k) Application Details - K943338

Device Classification Name	Monitor, Ultrasonic, Nonfetal   More FDA Info for this Device
510(K) Number	K943338
Device Name	Monitor, Ultrasonic, Nonfetal
Applicant	BIOSENSOR CORP. 13755 FIRST AVENUE NORTH PLYMOUTH, MN 55441 US Other 510(k) Applications for this Company
Contact	DARREN D DERSHEM Other 510(k) Applications for this Contact
Regulation Number	892.1540   More FDA Info for this Regulation Number
Classification Product Code	JAF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/12/1994
Decision Date	04/12/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review