Clearance Summary
GT990402 DIGITAL THERMOMETER received FDA 510(k) clearance under submission number K001279, sponsored by Global Treasure , 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 2000-04-28.
- Submission: K001279
- Applicant / Sponsor: Global Treasure , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 2000-04-28
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.