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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
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