21 CFR 868.5955 — Attachment, Intermittent Mandatory Ventilation (Imv)
Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5955
Identification
An intermittent mandatory ventilation (IMV) attachment is a device attached to a mechanical ventilator that allows spontaneous breathing by a patient while providing mechanical ventilation at a preset rate.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| CBO | Attachment, Intermittent Mandatory Ventilation (Imv) | 2 | 15 | Life-Sustaining |
