Clearance Summary
Hypotension Decision Assist Model HDA-OR2 received FDA 510(k) clearance under submission number K212529, sponsored by Directed Systems, 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 2021-11-23.
- Submission: K212529
- Applicant / Sponsor: Directed Systems, Ltd.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1435
- Decision date: 2021-11-23
Classification & Regulation
This clearance is catalogued under FDA product code DXG and 21 CFR 870.1435, within the Cardiovascular review panel as a Class II device.