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FDA 510(k) Application Details - K073665
Device Classification Name
Stimulator, Auditory, Evoked Response
More FDA Info for this Device
510(K) Number
K073665
Device Name
Stimulator, Auditory, Evoked Response
Applicant
NATUS MEDICAL, INC.
1501 INDUSTRIAL RD.
SAN CARLOS, CA 94070 US
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Contact
TOM BOLES
Other 510(k) Applications for this Contact
Regulation Number
882.1900
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Classification Product Code
GWJ
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More FDA Info for this Product Code
Date Received
12/26/2007
Decision Date
01/25/2008
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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