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FDA 510(k) Application Details - K041388
Device Classification Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
More FDA Info for this Device
510(K) Number
K041388
Device Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant
BIOMEDICAL LIFE SYSTEMS, INC.
2448 CADES WAY
P.O. BOX 1360
VISTA, CA 92085-1360 US
Other 510(k) Applications for this Company
Contact
GARY BUSSETT
Other 510(k) Applications for this Contact
Regulation Number
882.5890
More FDA Info for this Regulation Number
Classification Product Code
GZJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/25/2004
Decision Date
11/23/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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