FDA 510(k) Application Details - K964933

Device Classification Name	Dynamometer, Ac-Powered   More FDA Info for this Device
510(K) Number	K964933
Device Name	Dynamometer, Ac-Powered
Applicant	MEKANIKA, INC. 12500 S.W. 152ND ST. MIAMI, FL 33177-1411 US Other 510(k) Applications for this Company
Contact	DAVID C HOLMES Other 510(k) Applications for this Contact
Regulation Number	888.1240   More FDA Info for this Regulation Number
Classification Product Code	LBB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/10/1996
Decision Date	02/03/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review