Clearance Summary
3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E received FDA 510(k) clearance under submission number K193110, sponsored by 3M Healthcare. 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 2020-03-13.
- Submission: K193110
- Applicant / Sponsor: 3M Healthcare
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2800
- Decision date: 2020-03-13
Classification & Regulation
This clearance is catalogued under FDA product code QKM and 21 CFR 880.2800, within the General Hospital review panel as a Class II device.