Clearance Summary
DIGITAL THERMOMETER CLASSIC TYPE AND FLEXIBLE TYPE received FDA 510(k) clearance under submission number K023711, sponsored by Acute Ideas Co. , Ltd.. 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 2002-11-21.
- Submission: K023711
- Applicant / Sponsor: Acute Ideas Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 2002-11-21
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.