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FDA 510(k) Application Details - K162412
Device Classification Name
Dynamometer, Ac-Powered
More FDA Info for this Device
510(K) Number
K162412
Device Name
Dynamometer, Ac-Powered
Applicant
Hoggan Scientific, LLC
3653 West 1987 South Bld. # 7
Salt Lake City, UT 84104 US
Other 510(k) Applications for this Company
Contact
Spencer Walker
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
08/29/2016
Decision Date
03/09/2017
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
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