Clearance Summary
BT-338N ELECTRONIC CLINICAL THERMOMETER received FDA 510(k) clearance under submission number K894627, sponsored by Integrated Display Technology, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1989-10-23.
- Submission: K894627
- Applicant / Sponsor: Integrated Display Technology, Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1075
- Decision date: 1989-10-23
Classification & Regulation
This clearance is catalogued under FDA product code FCI and 21 CFR 876.1075, within the Gastroenterology, Urology review panel as a Class II device.