Clearance Summary
MI-328, MI-316, MI-388 DIGITAL THERMOMETER received FDA 510(k) clearance under submission number K893391, sponsored by Nam Tai Electronic & Electrical Products, 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 1989-06-23.
- Submission: K893391
- Applicant / Sponsor: Nam Tai Electronic & Electrical Products, Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 1989-06-23
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.