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510(k) K111514

SBV2, MULTICHARGER MODEL MC10V2 by Sleep Performance D.B.A. Fatigue Science — Product Code LEL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2011
Date Received
June 1, 2011
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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