K233096
- 510(k) number
- K233096
- Device name
- PRESSUREALERT® Pressure Monitoring System
- Applicant
- Position Health, LLC IL · US
- Product code
- SBO — Bed-Patient Activity Monitoring System
- Decision date
- 2024-06-21
- Date received
- 2023-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K233096.pdf
Official FDA record: K233096
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.