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FDA 510(k)

Phoenix

K-Number: K183152 · 2019-04-17

ApplicantUs Bionics, Inc. (Dba Suitx)
Decision Date2019-04-17
Product CodePHL
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Phoenix is a medical device manufactured by Us Bionics, Inc. (Dba Suitx). It received FDA 510(k) clearance on 2019-04-17 under approval number K183152. The device is classified under product code PHL. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Phoenix?

Phoenix is a medical device that received FDA 510(k) clearance on 2019-04-17. It is manufactured by Us Bionics, Inc. (Dba Suitx). The 510(k) number is K183152.

When was Phoenix approved by the FDA?

Phoenix received FDA 510(k) clearance on 2019-04-17, under approval number K183152.

What company makes Phoenix?

Phoenix is manufactured by Us Bionics, Inc. (Dba Suitx).

What is the FDA product code for Phoenix?

The FDA product code for Phoenix is PHL.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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