FDA 510(k)

PHantom Trilogy

K-Number: K213534 · 2022-03-11

Decision Date2022-03-11

Product CodeOLI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

PHantom Trilogy is the device name listed in this FDA 510(k) record. The listed applicant is Resurgeonz, LLC. It received FDA 510(k) clearance on 2022-03-11 under 510(k) number K213534. 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 PHantom Trilogy?

PHantom Trilogy is a medical device that received FDA 510(k) clearance on 2022-03-11. The listed applicant is Resurgeonz, LLC. The 510(k) number is K213534.

When did PHantom Trilogy receive FDA 510(k) clearance?

PHantom Trilogy received FDA 510(k) clearance on 2022-03-11, under 510(k) number K213534.

Who is the listed applicant for PHantom Trilogy?

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

What is the FDA product code for PHantom Trilogy?

The FDA product code for PHantom Trilogy is OLI.

Related Devices (Code: 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.