Skytron Universe Series Surgical Lights
FDA 510(k) K900211 · Skytron, Div. the Kmw Group, Inc.
510(k) numberK900211
Submission
- Device name
- Skytron Universe Series Surgical Lights
- Applicant
- Skytron, Div. the Kmw Group, Inc.
Grand Rapids, MI, US - Received
- January 17, 1990
- Decision date
- March 19, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FSY – Light, Surgical, Ceiling Mounted
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4580
- Specialty
- General, Plastic Surgery
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| K142984 | Leo MinorFSY · Traditional | Sunnex, Inc. | 10/29/2014SE |
| K142076 | Claveguard Freedom Surgical LightFSY · Traditional | Dickson & Dickson Healthcare (Us), Inc. | 09/30/2014SE |
| K140812 | MI-750 Procedural/Minor Surgical LightFSY · Traditional | Medical Illumination International, Inc. | 08/07/2014SE |
| K132551 | ZF 720FSY · Traditional | Umbel Corporation | 06/30/2014SE |
| K140930 | Vida LED Surgical Lighting System, V SeriesFSY · Traditional | Convida Healthcare & Systems Corporation | 06/09/2014SE |
| K140461 | Mach LED 2MCFSY · Special | Dr. Mach GmbH & Co. KG | 04/03/2014SE |
| K140460 | Mach LED 2SCFSY · Special | Dr. Mach GmbH & Co. KG | 04/03/2014SE |
| K132747 | Visum Blade LED Surgical Lighting SystemFSY · Traditional | Stryker Communications | 12/30/2013SE |
| K132307 | Vida LED Surgical Lighting SystemFSY · Traditional | Convida Healthcare & Systems Corporation | 11/05/2013SE |
| K131893 | Amico 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) | Device | Decision |
|---|---|---|
| K071698 | Aurora LED Series Surgical LightsFSY · Traditional | 07/06/2007SE |
| K021585 | Stellar Series Surgical Lights with HermesFSY · Traditional | 11/13/2002SE |
| K002463 | StellarFSY · Traditional | 11/08/2000SE |
| K992090 | Millennium GoldFSY · Traditional | 09/08/1999SE |
| K950192 | Skytron Skyboom SeriesFQO · Traditional | 04/03/1995SE |
| K940616 | Skytron Elite 3500 TableGDC · Traditional | 06/13/1994SE |
| K933564 | Skytron Exam LightKZF · Traditional | 02/10/1994SE |
| K926045 | Skytron Life Island 21FNM · Traditional | 07/27/1993SE |
| K915285 | Skytron Infinity Series Surgical LightsFSY · Traditional | 02/20/1992SE |
| K900472 | Skytron Model 860 and 800 Comp. Surgita Neuro EquiHBN · Traditional | 09/04/1990SE |
Questions and answers
When was Skytron Universe Series Surgical Lights cleared by the FDA?
Skytron Universe Series Surgical Lights (K900211) received a 510(k) decision of Substantially Equivalent on March 19, 1990, 61 days after the submission was received.
What is the product code of K900211?
The FDA product code is FSY – Light, Surgical, Ceiling Mounted, a Class II (moderate risk) device regulated under 21 CFR 878.4580.