21 CFR 868.2550 — Pneumotachometer
Anesthesiology (AN) · Part 868 Subpart C—Monitoring Devices · § 868.2550
Identification
A pneumotachometer is a device intended for medical purposes that is used to determine gas flow by measuring the pressure differential across a known resistance. The device may use a set of capillaries or a metal screen for the resistive element.
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JAX | Pneumotachometer | 2 | 8 |
Special Controls
JAX — Pneumotachometer
*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.
eCFR
