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)

THERMORITE MODEL HC-83 HYPO/HYPERTHERMIA UNIT

K-Number: K854856 · 1986-06-02

ApplicantThermorite, Inc.
Decision Date1986-06-02
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

THERMORITE MODEL HC-83 HYPO/HYPERTHERMIA UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Thermorite, Inc.. It received FDA 510(k) clearance on 1986-06-02 under 510(k) number K854856. The device is classified under product code DWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERMORITE MODEL HC-83 HYPO/HYPERTHERMIA UNIT?

THERMORITE MODEL HC-83 HYPO/HYPERTHERMIA UNIT is a medical device that received FDA 510(k) clearance on 1986-06-02. The listed applicant is Thermorite, Inc.. The 510(k) number is K854856.

When did THERMORITE MODEL HC-83 HYPO/HYPERTHERMIA UNIT receive FDA 510(k) clearance?

THERMORITE MODEL HC-83 HYPO/HYPERTHERMIA UNIT received FDA 510(k) clearance on 1986-06-02, under 510(k) number K854856.

Who is the listed applicant for THERMORITE MODEL HC-83 HYPO/HYPERTHERMIA UNIT?

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

What is the FDA product code for THERMORITE MODEL HC-83 HYPO/HYPERTHERMIA UNIT?

The FDA product code for THERMORITE MODEL HC-83 HYPO/HYPERTHERMIA UNIT is DWJ.

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: DWJ)

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.

K262089Disposable Warming BlanketHangzhou Tappa Medical Technology Co., Ltd.K261437Mistral-Air® Warming SystemThe Surgical Company International B.V., doing business as TSC LifeK260278ThermAffyx(TM) Patient Safety SystemStihler Electronic GmbHK260903Hot Pink Pad Warming SystemXodus Medical, Inc.K252861Warming SystemHangzhou Tappa Medical Technology Co., Ltd.K251974Arctic Sun Temperature Management System (Model 5000)Medivance, Inc.

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.

↑