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)

MI-4 VARIABLE SPOT LIGHT

K-Number: K931646 · 1993-08-19

ApplicantMedical Illumination, Inc.
Decision Date1993-08-19
Product CodeKZF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MI-4 VARIABLE SPOT LIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Medical Illumination, Inc.. It received FDA 510(k) clearance on 1993-08-19 under 510(k) number K931646. The device is classified under product code KZF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MI-4 VARIABLE SPOT LIGHT?

MI-4 VARIABLE SPOT LIGHT is a medical device that received FDA 510(k) clearance on 1993-08-19. The listed applicant is Medical Illumination, Inc.. The 510(k) number is K931646.

When did MI-4 VARIABLE SPOT LIGHT receive FDA 510(k) clearance?

MI-4 VARIABLE SPOT LIGHT received FDA 510(k) clearance on 1993-08-19, under 510(k) number K931646.

Who is the listed applicant for MI-4 VARIABLE SPOT LIGHT?

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

What is the FDA product code for MI-4 VARIABLE SPOT LIGHT?

The FDA product code for MI-4 VARIABLE SPOT LIGHT is KZF.

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 Medical Illumination, 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.

K931026MI-5 DIAGNOSTIC LIGHTK930897MI-15 EXAM SURGICAL LIGHTK925710M.E.D. LIGHTK922278ILLUMINATOR IIIK922282ILLUMINATOR VIII ULTRA/SPOTK922277ILLUMINATOR II

View all 10 devices →

Related Devices (Code: KZF)

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.

K954943NEVOSCOPENizar A. MullaniK952835WELCH ALLYN VIDEO EPISCOPEWelch Allyn, Inc.K945507H 5100, H 5200, H 5300Rudolf Riester GmbH & Co. KGK941869SPLINT, PNEUMATIC, ARM & SPLINT, PNEUMATIC, LEGThe Lighthouse For the Blind, Inc.K936088WAVE FLUORESCENT MAGNIFIERBurton Medical Products Corp.K940284MEDDEV MULTARRAY MEDICAL EXAMINING LIGHT MODIFICATIONMeddev International Corp.

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.

↑