Clearance Summary
Digital Electrocardiograph received FDA 510(k) clearance under submission number K160092, sponsored by Shenzhen Biocare Bio-Medical Equipment Co., Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2016-02-12.
- Submission: K160092
- Applicant / Sponsor: Shenzhen Biocare Bio-Medical Equipment Co., Ltd.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2340
- Decision date: 2016-02-12
Classification & Regulation
This clearance is catalogued under FDA product code DPS and 21 CFR 870.2340, within the Cardiovascular review panel as a Class II device.