21 CFR 868.5935 — Ventilator, External Body, Negative Pressure, Adult (Cuirass)
Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5935
Identification
An external negative pressure ventilator (e.g., iron lung, cuirass) is a device chamber that is intended to support a patient's ventilation by alternately applying and releasing external negative pressure over the diaphragm and upper trunk of the patient.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| BYT | Ventilator, External Body, Negative Pressure, Adult (Cuirass) | 2 | 21 | Life-Sustaining |
