Clearance Summary
MODEL GT980201 ELECTRONIC THERMOMETER received FDA 510(k) clearance under submission number K021028, 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 2002-04-08.
- Submission: K021028
- Applicant / Sponsor: Global Treasure , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 2002-04-08
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.