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FDA 510(k)

Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi White Pearl

K-Number: K170873 · 2017-10-02

ApplicantSwissmeditec GmbH
Decision Date2017-10-02
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi White Pearl is a medical device manufactured by Swissmeditec GmbH. It received FDA 510(k) clearance on 2017-10-02 under approval number K170873. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi White Pearl?

Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi White Pearl is a medical device that received FDA 510(k) clearance on 2017-10-02. It is manufactured by Swissmeditec GmbH. The 510(k) number is K170873.

When was Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi White Pearl approved by the FDA?

Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi White Pearl received FDA 510(k) clearance on 2017-10-02, under approval number K170873.

What company makes Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi White Pearl?

Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi White Pearl is manufactured by Swissmeditec GmbH.

What is the FDA product code for Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi White Pearl?

The FDA product code for Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi White Pearl is EBF.

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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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