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FDA 510(k)

Quantum Heater-Cooler

K-Number: K212657 · 2022-05-06

ApplicantSpectrum Medical , Ltd.
Decision Date2022-05-06
Product CodeDWC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Quantum Heater-Cooler is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Medical , Ltd.. It received FDA 510(k) clearance on 2022-05-06 under 510(k) number K212657. 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 Quantum Heater-Cooler?

Quantum Heater-Cooler is a medical device that received FDA 510(k) clearance on 2022-05-06. The listed applicant is Spectrum Medical , Ltd.. The 510(k) number is K212657.

When did Quantum Heater-Cooler receive FDA 510(k) clearance?

Quantum Heater-Cooler received FDA 510(k) clearance on 2022-05-06, under 510(k) number K212657.

Who is the listed applicant for Quantum Heater-Cooler?

The FDA 510(k) record lists Spectrum Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Quantum Heater-Cooler?

The FDA product code for Quantum Heater-Cooler is DWC.

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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.

K220635Heater-Cooler System 3TLivanova Deutschland, GmbHK191402Heater-Cooler System 3TLivanova Deutschland, GmbH

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.

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