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FDA 510(k)

LIFELINES IEEG

K-Number: K123665 · 2013-03-25

ApplicantKvikna Ehf
Decision Date2013-03-25
Product CodeOLT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

LIFELINES IEEG is the device name listed in this FDA 510(k) record. The listed applicant is Kvikna Ehf. It received FDA 510(k) clearance on 2013-03-25 under 510(k) number K123665. The device is classified under product code OLT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIFELINES IEEG?

LIFELINES IEEG is a medical device that received FDA 510(k) clearance on 2013-03-25. The listed applicant is Kvikna Ehf. The 510(k) number is K123665.

When did LIFELINES IEEG receive FDA 510(k) clearance?

LIFELINES IEEG received FDA 510(k) clearance on 2013-03-25, under 510(k) number K123665.

Who is the listed applicant for LIFELINES IEEG?

The FDA 510(k) record lists Kvikna Ehf as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIFELINES IEEG?

The FDA product code for LIFELINES IEEG is OLT.

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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.

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