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FDA 510(k)

ECMO-TEMP (TM) BLOOD WARMING DEVICE

K-Number: K873699 · 1987-12-22

ApplicantSeabrook Medical Systems, Inc.
Decision Date1987-12-22
Product CodeDWC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ECMO-TEMP (TM) BLOOD WARMING DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Seabrook Medical Systems, Inc.. It received FDA 510(k) clearance on 1987-12-22 under 510(k) number K873699. 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 ECMO-TEMP (TM) BLOOD WARMING DEVICE?

ECMO-TEMP (TM) BLOOD WARMING DEVICE is a medical device that received FDA 510(k) clearance on 1987-12-22. The listed applicant is Seabrook Medical Systems, Inc.. The 510(k) number is K873699.

When did ECMO-TEMP (TM) BLOOD WARMING DEVICE receive FDA 510(k) clearance?

ECMO-TEMP (TM) BLOOD WARMING DEVICE received FDA 510(k) clearance on 1987-12-22, under 510(k) number K873699.

Who is the listed applicant for ECMO-TEMP (TM) BLOOD WARMING DEVICE?

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

What is the FDA product code for ECMO-TEMP (TM) BLOOD WARMING DEVICE?

The FDA product code for ECMO-TEMP (TM) BLOOD WARMING DEVICE is DWC.

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Other records listing Seabrook Medical Systems, 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.

K952086TROPICAIR CONVECTIVE WARMING BLANKETSK946196TROPICAIR CONVECTIVE WARING SYSTEMK931203COOL-AIDK923104TROPIC-AIRK914182GOLDEN THERMAL(R)K902756TROPI-COOL

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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, AGK122813HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEMCincinnati Sub-Zero Products, Inc.K102147CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000Cardioquip Llp

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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