FDA 510(k) Application Details - K984307

Device Classification Name	System, Imaging, Pulsed Doppler, Ultrasonic   More FDA Info for this Device
510(K) Number	K984307
Device Name	System, Imaging, Pulsed Doppler, Ultrasonic
Applicant	HUNTLEIGH HEALTHCARE, INC. 227 RT. 33 EAST MANALAPAN, NJ 07726 US Other 510(k) Applications for this Company
Contact	AUDREY WITKO Other 510(k) Applications for this Contact
Regulation Number	892.1550   More FDA Info for this Regulation Number
Classification Product Code	IYN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/02/1998
Decision Date	01/12/1999
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