Clearance Summary
APM BLOOD PRESSURE MONITOR, MODEL BP108A received FDA 510(k) clearance under submission number K040159, sponsored by Asia Pacific Microsystems, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2004-03-22.
- Submission: K040159
- Applicant / Sponsor: Asia Pacific Microsystems, Inc.
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 2004-03-22
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.