510(k) K233096
- Device
- PRESSUREALERT® Pressure Monitoring System
- Applicant
- Position Health, LLC
- 510(k) number
- K233096
- Product code
- SBO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-06-21
- Date received
- 2023-09-26
- Regulation
- 880.2400
- Classification name
- Bed-Patient Activity Monitoring System
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Kristi Leigh
- Address
- 736 N. Western Ave., Suite 314 Lake Forest IL US 60045 60045
FDA Registration Numbers#
- 3039200836
- 3017415521
- 1424774