TSO3 Ozone Sterilizer, Model 125L
FDA 510(k) K020875 · Technologies of Sterilization With Oxone, Tso3, Inc.
510(k) numberK020875
Submission
- Device name
- TSO3 Ozone Sterilizer, Model 125L
- Applicant
- Technologies of Sterilization With Oxone, Tso3, Inc.
Fairport, NY, US - Received
- March 18, 2002
- Decision date
- August 26, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FLF – Sterilizer, Ethylene-Oxide Gas
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6860
- Specialty
- General Hospital
Other 510(k)s with product code FLF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K192978 | EOGas 4 Ethylene Oxide Gas SterilizerFLF · Traditional | Andersen Sterilizers, Inc. | 11/12/2020SE |
| K170432 | Anprolene AN75 Ethylene Oxide Gas SterilizerFLF · Traditional | Andersen Sterilizers, Inc. | 10/31/2017SE |
| K150646 | EOGas 4 Ethylene Oxide Gas SterilizerFLF · Traditional | Andersen Sterilizers, Inc. | 11/18/2015SE |
| K142034 | 3M Steri-Vac Sterilizer/AeratorFLF · Abbreviated | 3M Company | 01/08/2015SE |
| K090636 | TSO3 Ozone Sterilizer, Model 125LFLF · Traditional | Tso3, Inc. | 12/02/2009SE |
| K051595 | TSO3 Ozone Sterilizer, Model 125LFLF · Traditional | Tso3, Inc. | 07/26/2006SE |
| K014013 | H & W Hospital Ethylene Oxide Sterilizer Control SystemFLF · Abbreviated | H & W Technology, LLC | 06/25/2003SE |
| K023290 | Sterrad 50 & Sterrad 100S SterilizersFLF · Traditional | Advanced Sterilization Products | 04/03/2003SE |
| K923442 | Abtox Plazlyte Process MonitorFLF · Traditional | Abtox, Inc. | 12/22/1994SE |
| K905119 | Plazlyte(Tm)FLF · Traditional | Abtox, Inc. | 12/22/1994SE |
More from Abtox, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K021161 | TSO3 Ozone Chemical IndicatorJOJ · Traditional | 08/27/2003SE |
Questions and answers
When was TSO3 Ozone Sterilizer, Model 125L cleared by the FDA?
TSO3 Ozone Sterilizer, Model 125L (K020875) received a 510(k) decision of Substantially Equivalent on August 26, 2003, 526 days after the submission was received.
What is the product code of K020875?
The FDA product code is FLF – Sterilizer, Ethylene-Oxide Gas, a Class II (moderate risk) device regulated under 21 CFR 880.6860.