Illuminator III
FDA 510(k) K922278 · Medical Illumination, Inc.
510(k) numberK922278
Submission
- Device name
- Illuminator III
- Applicant
- Medical Illumination, Inc.
Arleta, CA, US - Received
- May 15, 1992
- Decision date
- March 4, 1993
- 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
Other 510(k)s with product code KZF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K954943 | NevoscopeKZF · Traditional | Nizar A. Mullani | 03/27/1996SE |
| K952835 | Welch Allyn Video EpiscopeKZF · Traditional | Welch Allyn, Inc. | 09/22/1995SE |
| 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 |
| K933564 | Skytron Exam LightKZF · Traditional | Skytron, Div. the Kmw Group, Inc. | 02/10/1994SE |
| 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 |
More from Midmark Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K931646 | MI-4 Variable Spot LightKZF · Traditional | 08/19/1993SE |
| K931026 | MI-5 Diagnostic LightKZF · Traditional | 08/19/1993SE |
| K930897 | MI-15 Exam Surgical LightFTD · Traditional | 06/25/1993SE |
| K925710 | M.E.D. LightKZF · Traditional | 06/04/1993SE |
| K922282 | Illuminator Viii Ultra/SpotKZF · Traditional | 03/04/1993SE |
| K922281 | Illuminator Vii Mini/Spot LightKZF · Traditional | 02/05/1993SE |
| K922280 | Illuminator Vii Mini/Lum LightKZF · Traditional | 02/05/1993SE |
| K922277 | Illuminator IIKZF · Traditional | 02/05/1993SE |
| K922279 | Illuminator IV Minor Surgery LightFSW · Traditional | 09/02/1992SE |
Questions and answers
When was Illuminator III cleared by the FDA?
Illuminator III (K922278) received a 510(k) decision of Substantially Equivalent on March 4, 1993, 293 days after the submission was received.
What is the product code of K922278?
The FDA product code is KZF – Device, Medical Examination, Ac Powered, a Class I (low risk) device regulated under 21 CFR 880.6320.