Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

THERMOCHEM HT-2000

K-Number: K131583 · 2013-10-03

ApplicantThermasolutions, Inc.
Decision Date2013-10-03
Product CodeMLW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

THERMOCHEM HT-2000 is the device name listed in this FDA 510(k) record. The listed applicant is Thermasolutions, Inc.. It received FDA 510(k) clearance on 2013-10-03 under 510(k) number K131583. 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-2000?

THERMOCHEM HT-2000 is a medical device that received FDA 510(k) clearance on 2013-10-03. The listed applicant is Thermasolutions, Inc.. The 510(k) number is K131583.

When did THERMOCHEM HT-2000 receive FDA 510(k) clearance?

THERMOCHEM HT-2000 received FDA 510(k) clearance on 2013-10-03, under 510(k) number K131583.

Who is the listed applicant for THERMOCHEM HT-2000?

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

What is the FDA product code for THERMOCHEM HT-2000?

The FDA product code for THERMOCHEM HT-2000 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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, LLCK020542DAYTRIPPER DIALYSATE WARMERStickman Industries, Inc.K993330THERMOCHEM-HT SYSTEMHemocleanse, Inc.K964825FREEDOM TRAVELLERImpact Case Technologies, Inc.K933619PD-PAKGeneral Medical Mfg. Co.

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.

↑