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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 the device name listed in this FDA 510(k) record. The listed applicant is Harmonus, Inc.. It received FDA 510(k) clearance on 2018-03-02 under 510(k) 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. The listed applicant is Harmonus, Inc.. The 510(k) number is K173312.

When did ProBx Software receive FDA 510(k) clearance?

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

Who is the listed applicant for ProBx Software?

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

What is the FDA product code for ProBx Software?

The FDA product code for ProBx Software is LLZ.

Related Devices (Code: LLZ)

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.

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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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