Clearance Summary
ELEX ELECTRONIC DIGITAL THERMOMETER received FDA 510(k) clearance under submission number K843609, sponsored by Ewing Intl. , 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 1985-01-25.
- Submission: K843609
- Applicant / Sponsor: Ewing Intl. , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 1985-01-25
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.