FDA 510(k) Application Details - K123746

Device Classification Name	System, Isokinetic Testing And Evaluation   More FDA Info for this Device
510(K) Number	K123746
Device Name	System, Isokinetic Testing And Evaluation
Applicant	AMES TECHNOLOGY, INC. 927 THRONE DRIVE EUGENE, OR 97402 US Other 510(k) Applications for this Company
Contact	SHEILA RAMERMAN, RAC Other 510(k) Applications for this Contact
Regulation Number	890.1925   More FDA Info for this Regulation Number
Classification Product Code	IKK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/06/2012
Decision Date	05/24/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review