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FDA 510(k) Application Details - K991853
Device Classification Name
Stimulator, Auditory, Evoked Response
More FDA Info for this Device
510(K) Number
K991853
Device Name
Stimulator, Auditory, Evoked Response
Applicant
IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE)
4814 EAST SECOND ST.
BENICIA, CA 94510 US
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Contact
DONNA WARD
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
06/01/1999
Decision Date
10/25/1999
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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