FDA 510(k) Application Details - K971528

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K971528
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	FUJINON, INC. 399 PARK AVE. NEW YORK, NY 10022-4689 US Other 510(k) Applications for this Company
Contact	GARY A ADLER 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	04/28/1997
Decision Date	12/12/1997
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