CCO · Bed, Rocking, Breathing Assist
Anesthesiology · 21 CFR 868.5180 · Class 2
Overview
| Product Code | CCO |
|---|---|
| Device Name | Bed, Rocking, Breathing Assist |
| Regulation | 21 CFR 868.5180 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| Life-Sustaining | Yes |
Identification
A rocking bed is a device intended for temporary use to help patient ventilation (breathing) by repeatedly tilting the patient, thereby using the weight of the abdominal contents to move the diaphragm.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
Cleared Devices (0)
No cleared devices on record.
