Clearance Summary
Endophys Blood Pressure Monitor model BPM-30 received FDA 510(k) clearance under submission number K231586, sponsored by Endophys Technologies, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2023-11-03.
- Submission: K231586
- Applicant / Sponsor: Endophys Technologies, LLC
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1110
- Decision date: 2023-11-03
Classification & Regulation
This clearance is catalogued under FDA product code DSK and 21 CFR 870.1110, within the Cardiovascular review panel as a Class II device.