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FDA 510(k)

Erchonia Zerona Z-Bed

K-Number: K220519 · 2022-03-24

Decision Date2022-03-24
Product CodeOLI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Erchonia Zerona Z-Bed is a medical device manufactured by Erchonia Corporation. It received FDA 510(k) clearance on 2022-03-24 under approval number K220519. The device is classified under product code OLI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Erchonia Zerona Z-Bed?

Erchonia Zerona Z-Bed is a medical device that received FDA 510(k) clearance on 2022-03-24. It is manufactured by Erchonia Corporation. The 510(k) number is K220519.

When was Erchonia Zerona Z-Bed approved by the FDA?

Erchonia Zerona Z-Bed received FDA 510(k) clearance on 2022-03-24, under approval number K220519.

What company makes Erchonia Zerona Z-Bed?

Erchonia Zerona Z-Bed is manufactured by Erchonia Corporation.

What is the FDA product code for Erchonia Zerona Z-Bed?

The FDA product code for Erchonia Zerona Z-Bed is OLI.

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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.