FDA 510(k)

SBV2, MULTICHARGER MODEL MC10V2

K-Number: K111514 · 2011-12-16

ApplicantSleep Performance D.B.A. Fatigue Science

Decision Date2011-12-16

Product CodeLEL

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

SBV2, MULTICHARGER MODEL MC10V2 is the device name listed in this FDA 510(k) record. The listed applicant is Sleep Performance D.B.A. Fatigue Science. It received FDA 510(k) clearance on 2011-12-16 under 510(k) number K111514. The device is classified under product code LEL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SBV2, MULTICHARGER MODEL MC10V2?

SBV2, MULTICHARGER MODEL MC10V2 is a medical device that received FDA 510(k) clearance on 2011-12-16. The listed applicant is Sleep Performance D.B.A. Fatigue Science. The 510(k) number is K111514.

When did SBV2, MULTICHARGER MODEL MC10V2 receive FDA 510(k) clearance?

SBV2, MULTICHARGER MODEL MC10V2 received FDA 510(k) clearance on 2011-12-16, under 510(k) number K111514.

Who is the listed applicant for SBV2, MULTICHARGER MODEL MC10V2?

The FDA 510(k) record lists Sleep Performance D.B.A. Fatigue Science as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SBV2, MULTICHARGER MODEL MC10V2?

The FDA product code for SBV2, MULTICHARGER MODEL MC10V2 is LEL.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.