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FDA 510(k) Application Details - K032833
Device Classification Name
Electrode, Cutaneous
More FDA Info for this Device
510(K) Number
K032833
Device Name
Electrode, Cutaneous
Applicant
OTTO BOCK HEALTH CARE, LP
2 CARLSON PWY. STE. 100
MINNEAPOLIS, MN 55447-4467 US
Other 510(k) Applications for this Company
Contact
BERT HARMAN
Other 510(k) Applications for this Contact
Regulation Number
882.1320
More FDA Info for this Regulation Number
Classification Product Code
GXY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/11/2003
Decision Date
09/23/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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