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FDA 510(k)

THERMOCHEM-HT SYSTEM

K-Number: K993330 · 1999-12-30

ApplicantHemocleanse, Inc.
Decision Date1999-12-30
Product CodeMLW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

THERMOCHEM-HT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hemocleanse, Inc.. It received FDA 510(k) clearance on 1999-12-30 under 510(k) number K993330. The device is classified under product code MLW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERMOCHEM-HT SYSTEM?

THERMOCHEM-HT SYSTEM is a medical device that received FDA 510(k) clearance on 1999-12-30. The listed applicant is Hemocleanse, Inc.. The 510(k) number is K993330.

When did THERMOCHEM-HT SYSTEM receive FDA 510(k) clearance?

THERMOCHEM-HT SYSTEM received FDA 510(k) clearance on 1999-12-30, under 510(k) number K993330.

Who is the listed applicant for THERMOCHEM-HT SYSTEM?

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

What is the FDA product code for THERMOCHEM-HT SYSTEM?

The FDA product code for THERMOCHEM-HT SYSTEM is MLW.

Related Clinical Trials

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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Other records listing Hemocleanse, 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.

K992196BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK)K984546BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TKK953751BIOLOGIC-DT SYSTEMK923046BIOLOGIC DT-1000 MACHINE

Related Devices (Code: MLW)

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.

K240447ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000)Thermasolutions, LLCK131583THERMOCHEM HT-2000Thermasolutions, Inc.K020542DAYTRIPPER DIALYSATE WARMERStickman Industries, Inc.K964825FREEDOM TRAVELLERImpact Case Technologies, Inc.K933619PD-PAKGeneral Medical Mfg. Co.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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