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FDA 510(k)

Novo

K-Number: K212361 · 2022-08-11

ApplicantPathAI, Inc.
Decision Date2022-08-11
Product CodeQKQ
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

Novo is a medical device manufactured by PathAI, Inc.. It received FDA 510(k) clearance on 2022-08-11 under approval number K212361. The device is classified under product code QKQ. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Novo?

Novo is a medical device that received FDA 510(k) clearance on 2022-08-11. It is manufactured by PathAI, Inc.. The 510(k) number is K212361.

When was Novo approved by the FDA?

Novo received FDA 510(k) clearance on 2022-08-11, under approval number K212361.

What company makes Novo?

Novo is manufactured by PathAI, Inc..

What is the FDA product code for Novo?

The FDA product code for Novo is QKQ.

Other Devices by PathAI, Inc.

K243391AISight Dx

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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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