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510(k) K965079

SOMNITOR 32K SLEEP ACTIVITY MONITOR by Neurim Pharmaceuticals, Ltd. — Product Code LEL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 1997
Date Received
December 19, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Sleep Assessment
Device Class
Class II
Regulation Number
882.5050
Review Panel
NE
Submission Type

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