Viotec 1400 Series Ultraviolet Germicidal Fixture
FDA 510(k) K943521 · Schiff & Co.
510(k) numberK943521
Submission
- Device name
- Viotec 1400 Series Ultraviolet Germicidal Fixture
- Applicant
- Schiff & Co.
West Cadwell, NJ, US - Received
- July 20, 1994
- Decision date
- February 14, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FRA – Purifier, Air, Ultraviolet, Medical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6500
- Specialty
- General Hospital
Other 510(k)s with product code FRA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252128 | Zener® (model ZEN-001-B1)FRA · Traditional | Uvx, Inc. | 09/15/2025SE |
| K241140 | ViroZap Indoor Air Purifier, In Duct Model 1008FRA · Traditional | Applied Photonix, LLC | 08/01/2024SE |
| K232642 | AirKEE T900FRA · Traditional | Healkee Medical Pte, Ltd. | 05/23/2024SE |
| K232933 | AirKEE P900FRA · Traditional | Healkee Medical Pte, Ltd. | 05/16/2024SE |
| K232645 | Airgle Room Air PurifierFRA · Traditional | Airgle Corporation | 02/16/2024SE |
| K221540 | Synexis Sphere RxFRA · Traditional | Synexis, LLC | 06/14/2023SE |
| K222702 | RGS; RGS MiniFRA · Traditional | Genesis Air, Inc. | 06/02/2023SE |
| K223328 | PurgoFRA · Special | Aeroclean Technologies, Inc. | 11/30/2022SE |
| K213753 | PurgoFRA · Traditional | Aeroclean Technologies, LLC | 06/01/2022SE |
| K212644 | Aura StormFRA · Traditional | Invictus Lighting | 05/26/2022SE |
More from Invictus Lighting
| 510(k) | Device | Decision |
|---|---|---|
| K990511 | X-Tip Intraosseous PerforatorDZM · Traditional | 04/27/1999SE |
| K982136 | Jostra Venous Hardshell Cardiotomic Reservoir VHK 4200DTN · Traditional | 03/24/1999SE |
| K981629 | Nutrisafe Enteral Feeding TubeFPD · Traditional | 02/04/1999SE |
| K981630 | Vygon Double Lumen Umbilical CatheterFOS · Traditional | 10/01/1998SE |
| K974141 | Plus Reusable ResuscitatorBTM · Traditional | 05/21/1998SE |
| K954448 | Viotec V-2200 Ultraviolet Germicidal Air Purification SystemFRA · Traditional | 10/28/1996SE |
| K955085 | Hm-Cap Eia Test (Modification)LYR · Traditional | 02/09/1996SE |
| K944159 | Hm-Cap Eia KitLYR · Traditional | 07/18/1995SE |
| K896684 | Kemble Liquid Handling System DispenserJQW · Traditional | 04/16/1990SE |
| K894617 | Olympus Pk-Tp System Reactive ControlGMI · Traditional | 10/31/1989SE |
Questions and answers
When was Viotec 1400 Series Ultraviolet Germicidal Fixture cleared by the FDA?
Viotec 1400 Series Ultraviolet Germicidal Fixture (K943521) received a 510(k) decision of Substantially Equivalent on February 14, 1995, 209 days after the submission was received.
What is the product code of K943521?
The FDA product code is FRA – Purifier, Air, Ultraviolet, Medical, a Class II (moderate risk) device regulated under 21 CFR 880.6500.