Clearance Summary
Swaive Thermometer SWT1A received FDA 510(k) clearance under submission number K170723, sponsored by E-Care Technology Co., 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 2018-10-25.
- Submission: K170723
- Applicant / Sponsor: E-Care Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 2018-10-25
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.