Clearance Summary
FUNET AMY MAMA BODY THERMOMETER received FDA 510(k) clearance under submission number K003326, sponsored by Funai Radio & Communications Corp.. 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 2001-04-11.
- Submission: K003326
- Applicant / Sponsor: Funai Radio & Communications Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 2001-04-11
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.