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FDA 510(k)

GrandioSO Light Flow

K-Number: K200294 · 2020-03-27

ApplicantVoco GmbH
Decision Date2020-03-27
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GrandioSO Light Flow is a medical device manufactured by Voco GmbH. It received FDA 510(k) clearance on 2020-03-27 under approval number K200294. 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 GrandioSO Light Flow?

GrandioSO Light Flow is a medical device that received FDA 510(k) clearance on 2020-03-27. It is manufactured by Voco GmbH. The 510(k) number is K200294.

When was GrandioSO Light Flow approved by the FDA?

GrandioSO Light Flow received FDA 510(k) clearance on 2020-03-27, under approval number K200294.

What company makes GrandioSO Light Flow?

GrandioSO Light Flow is manufactured by Voco GmbH.

What is the FDA product code for GrandioSO Light Flow?

The FDA product code for GrandioSO Light Flow 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.