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FDA 510(k)

ProBx Software

K-Number: K173312 · 2018-03-02

ApplicantHarmonus, Inc.
Decision Date2018-03-02
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ProBx Software is a medical device manufactured by Harmonus, Inc.. It received FDA 510(k) clearance on 2018-03-02 under approval number K173312. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ProBx Software?

ProBx Software is a medical device that received FDA 510(k) clearance on 2018-03-02. It is manufactured by Harmonus, Inc.. The 510(k) number is K173312.

When was ProBx Software approved by the FDA?

ProBx Software received FDA 510(k) clearance on 2018-03-02, under approval number K173312.

What company makes ProBx Software?

ProBx Software is manufactured by Harmonus, Inc..

What is the FDA product code for ProBx Software?

The FDA product code for ProBx Software is LLZ.

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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.

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