Clearance Summary
DYNAPULSE 5000A MINI ABP BLOOD PRESSURE MONITORING SYSTEM received FDA 510(k) clearance under submission number K013358, sponsored by Pulse Metric, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2001-12-13.
- Submission: K013358
- Applicant / Sponsor: Pulse Metric, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 2001-12-13
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.