Clearance Summary
BOSCH BLOOD PRESSURE METER (BP5000 BT) received FDA 510(k) clearance under submission number K131026, sponsored by Robert Bosch Healthcare Systems, 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 2013-11-14.
- Submission: K131026
- Applicant / Sponsor: Robert Bosch Healthcare Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 2013-11-14
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.