Clearance Summary
Wrist-type Fully Automatic Digital Blood Pressure Monitor received FDA 510(k) clearance under submission number K213189, sponsored by Joytech Healthcare 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 2022-03-01.
- Submission: K213189
- Applicant / Sponsor: Joytech Healthcare Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 2022-03-01
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.