Clearance Summary
DIGITAL THERMOMETER,HMCDT-002/KINETIK BRANDED DT1 SERIES received FDA 510(k) clearance under submission number K092557, sponsored by Harvard Medical Devices , 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 2009-12-17.
- Submission: K092557
- Applicant / Sponsor: Harvard Medical Devices , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 2009-12-17
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.