SBO — Bed-Patient Activity Monitoring System Class I
Classification Details
- Product Code
- SBO
- Device Class
- Class I
- Regulation Number
- 880.2400
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Definition
A bed-patient activity monitoring system is intended to monitor activity of patients while lying in a bed using pressure sensors placed on multiple parts of the body or locations under the mattress. The system may indicate by an alarm or other signal when patient activity deviates from assigned pressure prevention parameters.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K233096 | position health | PRESSUREALERT® Pressure Monitoring System | June 21, 2024 |