Essenz HLM
K-Number: K221373 · 2023-03-09
ApplicantLivanova Deutschland, GmbH
Decision Date2023-03-09
Product CodeDTQ
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Essenz HLM is a medical device manufactured by Livanova Deutschland, GmbH. It received FDA 510(k) clearance on 2023-03-09 under approval number K221373. 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 HLM is a medical device that received FDA 510(k) clearance on 2023-03-09. It is manufactured by Livanova Deutschland, GmbH. The 510(k) number is K221373.
When was Essenz HLM approved by the FDA?
Essenz HLM received FDA 510(k) clearance on 2023-03-09, under approval number K221373.
What company makes Essenz HLM?
Essenz HLM is manufactured by Livanova Deutschland, GmbH.
What is the FDA product code for Essenz HLM?
The FDA product code for Essenz HLM is DTQ.
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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.