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)

MILLENNIUM GOLD

K-Number: K992090 · 1999-09-08

ApplicantSkytron, Div. the Kmw Group, Inc.
Decision Date1999-09-08
Product CodeFSY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MILLENNIUM GOLD is the device name listed in this FDA 510(k) record. The listed applicant is Skytron, Div. the Kmw Group, Inc.. It received FDA 510(k) clearance on 1999-09-08 under 510(k) number K992090. The device is classified under product code FSY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MILLENNIUM GOLD?

MILLENNIUM GOLD is a medical device that received FDA 510(k) clearance on 1999-09-08. The listed applicant is Skytron, Div. the Kmw Group, Inc.. The 510(k) number is K992090.

When did MILLENNIUM GOLD receive FDA 510(k) clearance?

MILLENNIUM GOLD received FDA 510(k) clearance on 1999-09-08, under 510(k) number K992090.

Who is the listed applicant for MILLENNIUM GOLD?

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

What is the FDA product code for MILLENNIUM GOLD?

The FDA product code for MILLENNIUM GOLD is FSY.

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 Skytron, Div. the Kmw Group, 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.

K071698AURORA LED SERIES SURGICAL LIGHTSK021585STELLAR SERIES SURGICAL LIGHTS WITH HERMESK002463STELLARK950192SKYTRON SKYBOOM SERIESK940616SKYTRON ELITE 3500 TABLEK933564SKYTRON EXAM LIGHT

View all 19 devices →

Related Devices (Code: FSY)

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.

K132747VISUM BLADE LED SURGICAL LIGHTING SYSTEMStryker CommunicationsK132307VIDA LED SURGICAL LIGHTING SYSTEMConvida Healthcare & Systems CorporationK131893AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTSAjw Technology Consultants, Inc.K122875ORICARE L2700Oricare, Inc.K120392CHROMOPHARE F 628 AND F 528Berchtold GmbH & Co. KGK102758TRULIGHT 5520 AND TRULIGHT 5320Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg

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.

↑