SBO · Bed-Patient Activity Monitoring System
General Hospital · 21 CFR 880.2400 · Class 1
Overview
| Product Code | SBO |
|---|---|
| Device Name | Bed-Patient Activity Monitoring System |
| Regulation | 21 CFR 880.2400 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
Identification
A bed-patient monitor is a battery-powered device placed under a mattress and used to indicate by an alarm or other signal when a patient attempts to leave the bed.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K233096 | PRESSUREALERT® Pressure Monitoring System | Position Health, LLC | Jun 21, 2024 | SESE |
Top Applicants
- Position Health, LLC — 1 clearance
