Clearance Summary
DISPOSABLE THERMOMETER COVERS AND SHEATHS received FDA 510(k) clearance under submission number K112289, sponsored by Kang ZE Industrial Co. Limited. 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 2011-12-16.
- Submission: K112289
- Applicant / Sponsor: Kang ZE Industrial Co. Limited
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 2011-12-16
Classification & Regulation
This clearance is catalogued under FDA product code FLL and 21 CFR 880.2910, within the General Hospital review panel as a Class II device.