Heater-Cooler System 3T
K-Number: K220635 · 2022-11-16
Device Summary
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 2022-11-16. The listed applicant is Livanova Deutschland, GmbH. The 510(k) number is K220635.
When did Heater-Cooler System 3T receive FDA 510(k) clearance?
Heater-Cooler System 3T received FDA 510(k) clearance on 2022-11-16, under 510(k) number K220635.
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.
Related Devices (Code: DWC)
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.
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.