FDA 510(k) Application Details - K000960

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K000960
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	BARZELL-WHITMORE MAROON BELLS, INC. 962 ALLEGRO LN. APOLLO BEACH, FL 33572 US Other 510(k) Applications for this Company
Contact	ART WARD 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	03/24/2000
Decision Date	05/26/2000
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