21 CFR 868.2300 — Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge
Anesthesiology (AN) · Part 868 Subpart C—Monitoring Devices · § 868.2300
Identification
A bourdon gauge flowmeter is a device intended for medical purposes that is used in conjunction with respiratory equipment to sense gas pressure. The device is calibrated to indicate gas flow rate when the outflow is open to the atmosphere.
Classification Rationale
Class I (general 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 |
|---|---|---|---|---|
| CCN | Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge | 1 | 9 |
