FDA 510(k)

Essenz HLM, Essenz ILBM

K-Number: K232291 · 2023-08-24

Decision Date2023-08-24

Product CodeDTQ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Essenz HLM, Essenz ILBM is a medical device manufactured by Livanova Deutschland, GmbH. It received FDA 510(k) clearance on 2023-08-24 under approval number K232291. The device is classified under product code DTQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Essenz HLM, Essenz ILBM?

Essenz HLM, Essenz ILBM is a medical device that received FDA 510(k) clearance on 2023-08-24. It is manufactured by Livanova Deutschland, GmbH. The 510(k) number is K232291.

When was Essenz HLM, Essenz ILBM approved by the FDA?

Essenz HLM, Essenz ILBM received FDA 510(k) clearance on 2023-08-24, under approval number K232291.

What company makes Essenz HLM, Essenz ILBM?

Essenz HLM, Essenz ILBM is manufactured by Livanova Deutschland, GmbH.

What is the FDA product code for Essenz HLM, Essenz ILBM?

The FDA product code for Essenz HLM, Essenz ILBM is DTQ.

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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.