FDA 510(k)

Archer PSI System

K-Number: K243509 · 2025-05-12

Decision Date2025-05-12

Product CodeQHE

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Archer PSI System is a medical device manufactured by 3D-Side. It received FDA 510(k) clearance on 2025-05-12 under approval number K243509. The device is classified under product code QHE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Archer PSI System?

Archer PSI System is a medical device that received FDA 510(k) clearance on 2025-05-12. It is manufactured by 3D-Side. The 510(k) number is K243509.

When was Archer PSI System approved by the FDA?

Archer PSI System received FDA 510(k) clearance on 2025-05-12, under approval number K243509.

What company makes Archer PSI System?

Archer PSI System is manufactured by 3D-Side.

What is the FDA product code for Archer PSI System?

The FDA product code for Archer PSI System is QHE.

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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.