Clearance Summary
AIROCIDE TI02 received FDA 510(k) clearance under submission number K023830, sponsored by Kes Science & Technology, 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 2003-02-04.
- Submission: K023830
- Applicant / Sponsor: Kes Science & Technology, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6500
- Decision date: 2003-02-04
Classification & Regulation
This clearance is catalogued under FDA product code FRA and 21 CFR 880.6500, within the General Hospital review panel as a Class II device.