Millennium Gold

FDA 510(k) K992090 · Skytron, Div. the Kmw Group, Inc.

Substantially Equivalent

510(k) numberK992090

Submission

Device name
Millennium Gold
Applicant
Skytron, Div. the Kmw Group, Inc.
Grand Rapids, MI, US
Received
June 21, 1999
Decision date
September 8, 1999
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
FSY – Light, Surgical, Ceiling Mounted
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4580
Specialty
General, Plastic Surgery

Other 510(k)s with product code FSY

510(k)DeviceApplicantDecision
K142984Leo MinorFSY · Traditional Sunnex, Inc.10/29/2014SE
K142076Claveguard Freedom Surgical LightFSY · Traditional Dickson & Dickson Healthcare (Us), Inc.09/30/2014SE
K140812MI-750 Procedural/Minor Surgical LightFSY · Traditional Medical Illumination International, Inc.08/07/2014SE
K132551ZF 720FSY · Traditional Umbel Corporation06/30/2014SE
K140930Vida LED Surgical Lighting System, V SeriesFSY · Traditional Convida Healthcare & Systems Corporation06/09/2014SE
K140461Mach LED 2MCFSY · Special Dr. Mach GmbH & Co. KG04/03/2014SE
K140460Mach LED 2SCFSY · Special Dr. Mach GmbH & Co. KG04/03/2014SE
K132747Visum Blade LED Surgical Lighting SystemFSY · Traditional Stryker Communications12/30/2013SE
K132307Vida LED Surgical Lighting SystemFSY · Traditional Convida Healthcare & Systems Corporation11/05/2013SE
K131893Amico Ce Series Surgical Lights, Mira LED Series Minor Surgical LightsFSY · Traditional Ajw Technology Consultants, Inc.10/30/2013SE

More from Ajw Technology Consultants, Inc.

510(k)DeviceDecision
K071698Aurora LED Series Surgical LightsFSY · Traditional 07/06/2007SE
K021585Stellar Series Surgical Lights with HermesFSY · Traditional 11/13/2002SE
K002463StellarFSY · Traditional 11/08/2000SE
K950192Skytron Skyboom SeriesFQO · Traditional 04/03/1995SE
K940616Skytron Elite 3500 TableGDC · Traditional 06/13/1994SE
K933564Skytron Exam LightKZF · Traditional 02/10/1994SE
K926045Skytron Life Island 21FNM · Traditional 07/27/1993SE
K915285Skytron Infinity Series Surgical LightsFSY · Traditional 02/20/1992SE
K900472Skytron Model 860 and 800 Comp. Surgita Neuro EquiHBN · Traditional 09/04/1990SE
K900211Skytron Universe Series Surgical LightsFSY · Traditional 03/19/1990SE

Questions and answers

When was Millennium Gold cleared by the FDA?

Millennium Gold (K992090) received a 510(k) decision of Substantially Equivalent on September 8, 1999, 79 days after the submission was received.

What is the product code of K992090?

The FDA product code is FSY – Light, Surgical, Ceiling Mounted, a Class II (moderate risk) device regulated under 21 CFR 878.4580.