Clearance Summary
AMBULATORY BLOOD PRESSURE MONITOR received FDA 510(k) clearance under submission number K830368, sponsored by Vita-Stat Medical Services, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1983-03-31.
- Submission: K830368
- Applicant / Sponsor: Vita-Stat Medical Services, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 1983-03-31
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.