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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 a medical device manufactured by Comerge AG. It received FDA 510(k) clearance on 2024-03-08 under approval 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. It is manufactured by Comerge AG. The 510(k) number is K230195.

When was Neo ADVISE software approved by the FDA?

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

What company makes Neo ADVISE software?

Neo ADVISE software is manufactured by Comerge AG.

What is the FDA product code for Neo ADVISE software?

The FDA product code for Neo ADVISE software is OLO.

Other Devices by Comerge AG

K252104T1D1

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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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