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FDA 510(k)

HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM

K-Number: K122813 · 2012-12-18

ApplicantCincinnati Sub-Zero Products, Inc.
Decision Date2012-12-18
Product CodeDWC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cincinnati Sub-Zero Products, Inc.. It received FDA 510(k) clearance on 2012-12-18 under 510(k) number K122813. 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 HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM?

HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM is a medical device that received FDA 510(k) clearance on 2012-12-18. The listed applicant is Cincinnati Sub-Zero Products, Inc.. The 510(k) number is K122813.

When did HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM receive FDA 510(k) clearance?

HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM received FDA 510(k) clearance on 2012-12-18, under 510(k) number K122813.

Who is the listed applicant for HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM?

The FDA 510(k) record lists Cincinnati Sub-Zero Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM?

The FDA product code for HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM is DWC.

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Other records listing Cincinnati Sub-Zero Products, Inc. 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.

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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, GmbHK212657Quantum Heater-CoolerSpectrum Medical , Ltd.K191402Heater-Cooler System 3TLivanova Deutschland, GmbHK130300HEATER-COOLER UNIT HCU 40Maquet Cardiopulmonary, AGK102147CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000Cardioquip LlpK071521TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEMTerumo Cardiovascular Systems Corp.

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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