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510(k) K111514

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

K111514 is an FDA 510(k) premarket notification submitted by Sleep Performance D.B.A. Fatigue Science for the device "SBV2, MULTICHARGER MODEL MC10V2". The FDA issued a decision of Substantially Equivalent on December 16, 2011. The device falls under product code LEL (Device, Sleep Assessment), a Class II device regulated under 21 CFR 882.5050.

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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FDA data resources