FDA 510(k) Application Details - K011827

Device Classification Name	Goniometer, Ac-Powered   More FDA Info for this Device
510(K) Number	K011827
Device Name	Goniometer, Ac-Powered
Applicant	ORTHOSCAN LTD. 17 AHUZAH ST. RA'ANANNA 43373 IL Other 510(k) Applications for this Company
Contact	SHOSHANA FRIEDMAN Other 510(k) Applications for this Contact
Regulation Number	888.1500   More FDA Info for this Regulation Number
Classification Product Code	KQX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/12/2001
Decision Date	08/28/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review