Skytron Exam Light
FDA 510(k) K933564 · Skytron, Div. the Kmw Group, Inc.
510(k) numberK933564
Submission
- Device name
- Skytron Exam Light
- Applicant
- Skytron, Div. the Kmw Group, Inc.
Grand Rapids, MI, US - Received
- July 22, 1993
- Decision date
- February 10, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KZF – Device, Medical Examination, Ac Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6320
- Specialty
- General Hospital
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| K945507 | H 5100, H 5200, H 5300KZF · Traditional | Rudolf Riester GmbH & Co. KG | 12/09/1994SE |
| K941869 | Splint, Pneumatic, Arm & Splint, Pneumatic, LegKZF · Traditional | The Lighthouse For the Blind, Inc. | 08/03/1994SE |
| K936088 | Wave Fluorescent MagnifierKZF · Traditional | Burton Medical Products Corp. | 04/26/1994SE |
| K940284 | Meddev Multarray Medical Examining Light ModificationKZF · Traditional | Meddev International Corp. | 02/28/1994SE |
| K935832 | ChromophareKZF · Traditional | Berchtold Holding GmbH | 02/03/1994SE |
| K934259 | Ac-Powered Medical Examination LightKZF · Traditional | Welch Allyn, Inc. | 01/28/1994SE |
| K932719 | Ritter Model 158 and 159 Exam LightsKZF · Traditional | Midmark Corp. | 12/02/1993SE |
| K924447 | VitapenKZF · Traditional | Vitajet Corp. | 09/27/1993SE |
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| K950192 | Skytron Skyboom SeriesFQO · Traditional | 04/03/1995SE |
| K940616 | Skytron Elite 3500 TableGDC · Traditional | 06/13/1994SE |
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| K915285 | Skytron Infinity Series Surgical LightsFSY · Traditional | 02/20/1992SE |
| K900472 | Skytron Model 860 and 800 Comp. Surgita Neuro EquiHBN · Traditional | 09/04/1990SE |
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Questions and answers
When was Skytron Exam Light cleared by the FDA?
Skytron Exam Light (K933564) received a 510(k) decision of Substantially Equivalent on February 10, 1994, 203 days after the submission was received.
What is the product code of K933564?
The FDA product code is KZF – Device, Medical Examination, Ac Powered, a Class I (low risk) device regulated under 21 CFR 880.6320.