21 CFR 868.2600 — Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Anesthesiology (AN) · Part 868 Subpart C—Monitoring Devices · § 868.2600
Identification
An airway pressure monitor is a device used to measure the pressure in a patient's upper airway. The device may include a pressure gauge and an alarm.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 2 | 78 | 3rd Party |