21 CFR 868.2320 — Tube, Thorpe, Uncompensated
Anesthesiology (AN) · Part 868 Subpart C—Monitoring Devices · § 868.2320
Identification
An uncompensated thorpe tube flowmeter is a device intended for medical purposes that is used to indicate and control gas flow rate accurately. The device includes a vertically mounted tube and is calibrated when the outlet of the flowmeter 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 |
|---|---|---|---|---|
| BYM | Tube, Thorpe, Uncompensated | 1 | 1 |
