21 CFR 868.5965 — Attachment, Breathing, Positive End Expiratory Pressure
Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5965
Identification
A positive end expiratory pressure (PEEP) breathing attachment is a device attached to a ventilator that is used to elevate pressure in a patient's lungs above atmospheric pressure at the end of exhalation.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 2 | 80 | Life-Sustaining |
