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FDA 510(k) Application Details - K002734
Device Classification Name
Electrode, Cutaneous
More FDA Info for this Device
510(K) Number
K002734
Device Name
Electrode, Cutaneous
Applicant
ASPECT MEDICAL SYSTEMS, INC.
141 NEEDHAM ST.
NEWTON, MA 02464 US
Other 510(k) Applications for this Company
Contact
CHRISTINE M VOZELLA
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
09/01/2000
Decision Date
09/14/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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