21 CFR 880.2400 — Monitor, Bed Patient
General Hospital (HO) · Part 880 Subpart C—General Hospital and Personal Use Monitoring Devices · § 880.2400
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KMI | Monitor, Bed Patient | 1 | 31 | |
| PJO | Fall Prevention Alarm/Sensor Combination Attached Or Unattached | 1 | 0 | |
| PJP | Fall Prevention Alarm/Sensor Attached Only | 1 | 0 | |
| SBO | Bed-Patient Activity Monitoring System | 1 | 1 | SaMD |
