Clearance Summary
GOOD MEDY, DISPOSABLE THERMOMETER SHEATHS received FDA 510(k) clearance under submission number K061007, sponsored by Good Medy Enterprise , 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 2006-06-14.
- Submission: K061007
- Applicant / Sponsor: Good Medy Enterprise , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 2006-06-14
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.