FDA 510(k)

Heater-Cooler System 3T

K-Number: K191402 · 2020-02-25

Decision Date2020-02-25

Product CodeDWC

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Heater-Cooler System 3T is the device name listed in this FDA 510(k) record. The listed applicant is Livanova Deutschland, GmbH. It received FDA 510(k) clearance on 2020-02-25 under 510(k) number K191402. The device is classified under product code DWC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Heater-Cooler System 3T?

Heater-Cooler System 3T is a medical device that received FDA 510(k) clearance on 2020-02-25. The listed applicant is Livanova Deutschland, GmbH. The 510(k) number is K191402.

When did Heater-Cooler System 3T receive FDA 510(k) clearance?

Heater-Cooler System 3T received FDA 510(k) clearance on 2020-02-25, under 510(k) number K191402.

Who is the listed applicant for Heater-Cooler System 3T?

The FDA 510(k) record lists Livanova Deutschland, GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Heater-Cooler System 3T?

The FDA product code for Heater-Cooler System 3T is DWC.

Other records listing Livanova Deutschland, GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232291Essenz HLM, Essenz ILBM K221373Essenz HLM K220635Heater-Cooler System 3T K212003ESSENZ Patient Monitor K210130Stockert S5 System K202154B-Capta

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Related Devices (Code: DWC)

K220635Heater-Cooler System 3TLivanova Deutschland, GmbH K212657Quantum Heater-CoolerSpectrum Medical , Ltd.

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.