SBV2, MULTICHARGER MODEL MC10V2— 510(k) K111514

Name: FDA 510(k) clearance K111514
Creator: U.S. Food and Drug Administration
Published: 2011-12-16

Substantially Equivalent

Sleep Performance D.B.A. Fatigue Science

FDA 510(k) clearance K111514 for SBV2, MULTICHARGER MODEL MC10V2, Substantially Equivalent on 2011-12-16. Applicant: Sleep Performance D.B.A. Fatigue Science. Device class: 2.

Clearance details

Applicant: Sleep Performance D.B.A. Fatigue Science
Product code: Code LEL
Device class: Class 2
Regulation: 21 CFR 882.5050
Advisory panel: Neurology
Date received: 2011-06-01
Decision date: 2011-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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