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FDA 510(k) Application Details - K151156
Device Classification Name
Neurological Stereotaxic Instrument
More FDA Info for this Device
510(K) Number
K151156
Device Name
Neurological Stereotaxic Instrument
Applicant
FIAGON GMBH
NEUENDORFSTRASSE 23B
HENNIGSDORF 16761 DE
Other 510(k) Applications for this Company
Contact
DIRK MUCHA
Other 510(k) Applications for this Contact
Regulation Number
882.4560
More FDA Info for this Regulation Number
Classification Product Code
HAW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/01/2015
Decision Date
04/01/2016
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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