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FDA 510(k) Application Details - K071782
Device Classification Name
Standard Polysomnograph With Electroencephalograph
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510(K) Number
K071782
Device Name
Standard Polysomnograph With Electroencephalograph
Applicant
MICROMED S.P.A.
VIA GIOTTO 2
MOGLIANO VENETO (TV) 31021 IT
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Contact
MONICA CAMILLO
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Regulation Number
882.1400
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Classification Product Code
OLV
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Date Received
07/02/2007
Decision Date
01/10/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
Y
Expedited Review
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