BYM · Tube, Thorpe, Uncompensated
Anesthesiology · 21 CFR 868.2320 · Class 1
Overview
| Product Code | BYM |
|---|---|
| Device Name | Tube, Thorpe, Uncompensated |
| Regulation | 21 CFR 868.2320 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K810314 | WILLIAM HARVEY FLOWMETER SYSTEM | C.R. Bard, Inc. | Feb 19, 1981 | SESE |
Top Applicants
- C.R. Bard, Inc. — 1 clearance
