FDA 510(k) Application Details - K020876

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K020876
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	NIDEK, INC. 21911 ERIE LN. LAKE FOREST, CA 92630 US Other 510(k) Applications for this Company
Contact	CAROL PATTERSON 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	03/18/2002
Decision Date	05/03/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review