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)

LSI6000 THERMAL THERAPY SYSTEM

K-Number: K926151 · 1993-05-26

ApplicantBurke Neutech, Inc.
Decision Date1993-05-26
Product CodeILO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

LSI6000 THERMAL THERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Burke Neutech, Inc.. It received FDA 510(k) clearance on 1993-05-26 under 510(k) number K926151. The device is classified under product code ILO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LSI6000 THERMAL THERAPY SYSTEM?

LSI6000 THERMAL THERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 1993-05-26. The listed applicant is Burke Neutech, Inc.. The 510(k) number is K926151.

When did LSI6000 THERMAL THERAPY SYSTEM receive FDA 510(k) clearance?

LSI6000 THERMAL THERAPY SYSTEM received FDA 510(k) clearance on 1993-05-26, under 510(k) number K926151.

Who is the listed applicant for LSI6000 THERMAL THERAPY SYSTEM?

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

What is the FDA product code for LSI6000 THERMAL THERAPY SYSTEM?

The FDA product code for LSI6000 THERMAL THERAPY SYSTEM is ILO.

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

Other records listing Burke Neutech, 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.

K955326SPORTS CONTRAST THERAPY SYSTEM ST 7000K952117EPILATORK943497CONTRAST 7000 THERAPY SYSTEMK945803THERMAFLEX, MODEL SD 55 C.P.M.H.K942926NEURO-AIDEK940160TS1000 PORTABLE DISPOSABLE COLD THERAPY SYSTEM

View all 7 devices →

Related Devices (Code: ILO)

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.

K213097Armory MotionPain Management Technologies, Inc.K083008COOLSKINElbio Co., Ltd.K073675T-PUMP LOCALIZED TEMPERATURE THERAPY PUMPGaymar Industries, Inc.K072152JUNIPER CLN1 DERMAL COOLING DEVICEJuniper Medical, Inc.K070402MODIFICATION TO POLAR CARE 500Breg, Inc.K040317IVC SYSTEMMark H. Friedman

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.

↑