Clearance Summary
A&D MEDICAL UT-101 LIFESOURCE DIGITAL EAR THEROMETER received FDA 510(k) clearance under submission number K993116, sponsored by A&D Engineering, Inc.. 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 2000-04-12.
- Submission: K993116
- Applicant / Sponsor: A&D Engineering, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 2000-04-12
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.