Clearance Summary
TSO3 OZONE CHEMICAL INDICATOR received FDA 510(k) clearance under submission number K021161, sponsored by Technologies of Sterilization With Oxone, Tso3, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2003-08-27.
- Submission: K021161
- Applicant / Sponsor: Technologies of Sterilization With Oxone, Tso3, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2800
- Decision date: 2003-08-27
Classification & Regulation
This clearance is catalogued under FDA product code JOJ and 21 CFR 880.2800, within the General Hospital review panel as a Class II device.