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FDA 510(k) Application Details - K171397
Device Classification Name
Amplifier, Physiological Signal
More FDA Info for this Device
510(K) Number
K171397
Device Name
Amplifier, Physiological Signal
Applicant
EMS Handels Gesellschaft m.b.H.
Jochingergasse 1
Korneuburg A-2100 AT
Other 510(k) Applications for this Company
Contact
Ruzena Ortnerova
Other 510(k) Applications for this Contact
Regulation Number
882.1835
More FDA Info for this Regulation Number
Classification Product Code
GWL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/11/2017
Decision Date
10/06/2017
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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