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)

LSI SYSTEM II

K-Number: K904743 · 1991-09-04

ApplicantM.S.P. , Ltd.
Decision Date1991-09-04
Product CodeLIH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

LSI SYSTEM II is the device name listed in this FDA 510(k) record. The listed applicant is M.S.P. , Ltd.. It received FDA 510(k) clearance on 1991-09-04 under 510(k) number K904743. The device is classified under product code LIH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LSI SYSTEM II?

LSI SYSTEM II is a medical device that received FDA 510(k) clearance on 1991-09-04. The listed applicant is M.S.P. , Ltd.. The 510(k) number is K904743.

When did LSI SYSTEM II receive FDA 510(k) clearance?

LSI SYSTEM II received FDA 510(k) clearance on 1991-09-04, under 510(k) number K904743.

Who is the listed applicant for LSI SYSTEM II?

The FDA 510(k) record lists M.S.P. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LSI SYSTEM II?

The FDA product code for LSI SYSTEM II is LIH.

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 M.S.P. , Ltd. 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.

K925680LSI SYSTEM IV INTERFERENTIAL,MUSCLE STIMULATORK922529POWERED MUSCLE STIMULATOR

Related Devices (Code: LIH)

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.

K231575Vecttor VT-300Artaflex, Inc.K202725ETD4000Therasigma, LLCK183692Avid IF2Vision Quest Industries Inc./Dba VQ OrthocareK122944GEMORE TRUE SINE INTERFERENTIAL STIMULATORGemore Technology Co, Ltd.K121662VECTTOR VT-200Alan Neuromedical Technologies, LLCK110509EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908Everyway Medical Instruments Co.,Ltd

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.

↑