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510(k) K071782

MICROMED BRAIN SPY PLUS, EMBIA TITANIUM DEVICES by Micromed S.P.A. — Product Code OLV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 2008
Date Received
July 2, 2007
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Standard Polysomnograph With Electroencephalograph
Device Class
Class II
Regulation Number
882.1400
Review Panel
NE
Submission Type

Acquire, display, store, and archive electroencephalographic signals from the brain and other signals (such as electromyography, respiratory and/or oximetry signals) for sleep recordings. May also be used to allow on-screen review, user-controlled annotation and user-controlled marking of data.

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