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FDA 510(k) Application Details - K991045
Device Classification Name
Conditioner, Signal, Physiological
More FDA Info for this Device
510(K) Number
K991045
Device Name
Conditioner, Signal, Physiological
Applicant
MINI-MITTER CO., INC.
PO BOX 3386
SUNRIVER, OR 97707 US
Other 510(k) Applications for this Company
Contact
JACK E MCKENZIE
Other 510(k) Applications for this Contact
Regulation Number
882.1845
More FDA Info for this Regulation Number
Classification Product Code
GWK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/29/1999
Decision Date
09/21/1999
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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