Clearance Summary
VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag received FDA 510(k) clearance under submission number K182931, sponsored by Steris Corporations. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2018-11-20.
- Submission: K182931
- Applicant / Sponsor: Steris Corporations
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2800
- Decision date: 2018-11-20
Classification & Regulation
This clearance is catalogued under FDA product code FRC and 21 CFR 880.2800, within the General Hospital review panel as a Class II device.