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FDA 510(k)

eVolve PACS

K-Number: K211863 · 2021-08-12

ApplicantEvolve Pacs, Inc.
Decision Date2021-08-12
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

eVolve PACS is a medical device manufactured by Evolve Pacs, Inc.. It received FDA 510(k) clearance on 2021-08-12 under approval number K211863. 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 eVolve PACS?

eVolve PACS is a medical device that received FDA 510(k) clearance on 2021-08-12. It is manufactured by Evolve Pacs, Inc.. The 510(k) number is K211863.

When was eVolve PACS approved by the FDA?

eVolve PACS received FDA 510(k) clearance on 2021-08-12, under approval number K211863.

What company makes eVolve PACS?

eVolve PACS is manufactured by Evolve Pacs, Inc..

What is the FDA product code for eVolve PACS?

The FDA product code for eVolve PACS 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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