Viotec V-2200 Ultraviolet Germicidal Air Purification System
FDA 510(k) K954448 · Schiff & Co.
510(k) numberK954448
Submission
- Device name
- Viotec V-2200 Ultraviolet Germicidal Air Purification System
- Applicant
- Schiff & Co.
West Cadwell, NJ, US - Received
- September 25, 1995
- Decision date
- October 28, 1996
- 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
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| 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 |
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| K955085 | Hm-Cap Eia Test (Modification)LYR · Traditional | 02/09/1996SE |
| K944159 | Hm-Cap Eia KitLYR · Traditional | 07/18/1995SE |
| K943521 | Viotec 1400 Series Ultraviolet Germicidal FixtureFRA · Traditional | 02/14/1995SE |
| 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 V-2200 Ultraviolet Germicidal Air Purification System cleared by the FDA?
Viotec V-2200 Ultraviolet Germicidal Air Purification System (K954448) received a 510(k) decision of Substantially Equivalent on October 28, 1996, 399 days after the submission was received.
What is the product code of K954448?
The FDA product code is FRA – Purifier, Air, Ultraviolet, Medical, a Class II (moderate risk) device regulated under 21 CFR 880.6500.