Clearance Summary
PRESSUREALERT® Pressure Monitoring System received FDA 510(k) clearance under submission number K233096, sponsored by Position Health, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2024-06-21.
- Submission: K233096
- Applicant / Sponsor: Position Health, LLC
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.2400
- Decision date: 2024-06-21
Classification & Regulation
This clearance is catalogued under FDA product code SBO and 21 CFR 880.2400, within the General Hospital review panel as a Class I device.