FDA 510(k) Application Details - K973857

Device Classification Name	Monitor, Ultrasonic, Nonfetal   More FDA Info for this Device
510(K) Number	K973857
Device Name	Monitor, Ultrasonic, Nonfetal
Applicant	BIOMEDIX, INC. P.O. BOX 1419 CAMDEN, NJ 08105 US Other 510(k) Applications for this Company
Contact	DAVID LERNER 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	10/09/1997
Decision Date	12/29/1997
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