21 CFR 868.2350 — Flowmeter, Calibration, Gas
Anesthesiology (AN) · Part 868 Subpart C—Monitoring Devices · § 868.2350
Identification
A gas calibration flowmeter is a device intended for medical purposes that is used to calibrate flowmeters and accurately measure gas flow.
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 |
|---|---|---|---|---|
| BXY | Flowmeter, Calibration, Gas | 1 | 7 |
