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FDA 510(k) Application Details - K962764
Device Classification Name
Magnetoencephalograph
More FDA Info for this Device
510(K) Number
K962764
Device Name
Magnetoencephalograph
Applicant
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
5500 AVION PARK DR.
HIGHLAND HEIGHTS, OH 44143 US
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Contact
ELAINE K KEELER
Other 510(k) Applications for this Contact
Regulation Number
882.1400
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Classification Product Code
OLY
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More FDA Info for this Product Code
Date Received
07/16/1996
Decision Date
10/31/1996
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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