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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 the device name listed in this FDA 510(k) record. The listed applicant is Erchonia Corporation. It received FDA 510(k) clearance on 2022-03-24 under 510(k) 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. The listed applicant is Erchonia Corporation. The 510(k) number is K220519.

When did Erchonia Zerona Z-Bed receive FDA 510(k) clearance?

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

Who is the listed applicant for Erchonia Zerona Z-Bed?

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

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

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing Erchonia Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 17 devices →

Related Devices (Code: OLI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.