PJP · Fall Prevention Alarm/Sensor Attached Only
General Hospital · 21 CFR 880.2400 · Class 1
Overview
| Product Code | PJP |
|---|---|
| Device Name | Fall Prevention Alarm/Sensor Attached Only |
| 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 (0 of 0)
No cleared devices on record.
