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FDA 510(k)

Neo ADVISE software

K-Number: K230195 · 2024-03-08

ApplicantComerge AG
Decision Date2024-03-08
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Neo ADVISE software is the device name listed in this FDA 510(k) record. The listed applicant is Comerge AG. It received FDA 510(k) clearance on 2024-03-08 under 510(k) number K230195. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Neo ADVISE software?

Neo ADVISE software is a medical device that received FDA 510(k) clearance on 2024-03-08. The listed applicant is Comerge AG. The 510(k) number is K230195.

When did Neo ADVISE software receive FDA 510(k) clearance?

Neo ADVISE software received FDA 510(k) clearance on 2024-03-08, under 510(k) number K230195.

Who is the listed applicant for Neo ADVISE software?

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

What is the FDA product code for Neo ADVISE software?

The FDA product code for Neo ADVISE software is OLO.

Other records listing Comerge AG as applicant

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.

K252104T1D1

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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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