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FDA 510(k) Application Details - K961642
Device Classification Name
Electroencephalograph
More FDA Info for this Device
510(K) Number
K961642
Device Name
Electroencephalograph
Applicant
OXFORD INSTRUMENTS, PLC.
11526 53RD ST. N.
CLEARWATER, FL 34620 US
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Contact
CHARLES HOLZ
Other 510(k) Applications for this Contact
Regulation Number
882.1400
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Classification Product Code
GWQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/29/1996
Decision Date
01/17/1997
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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