Clearance Summary
AGE Automatic Wrist Blood Pressure Monitor received FDA 510(k) clearance under submission number K193628, sponsored by Dongguan E-Test Technology Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2020-07-12.
- Submission: K193628
- Applicant / Sponsor: Dongguan E-Test Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 2020-07-12
Classification & Regulation
This clearance is catalogued under FDA product code DXN and 21 CFR 870.1130, within the Cardiovascular review panel as a Class II device.