BYW · Device, Rebreathing
Anesthesiology · 21 CFR 868.5675 · Class 1
Overview
| Product Code | BYW |
|---|---|
| Device Name | Device, Rebreathing |
| Regulation | 21 CFR 868.5675 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
Identification
A rebreathing device is a device that enables a patient to rebreathe exhaled gases. It may be used in conjunction with pulmonary function testing or for increasing minute ventilation.
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 § 868.9.
Cleared Devices (2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K895274 | HYPEX | Global Business, Inc. | Feb 23, 1990 | SESE |
| K802165 | SHERWOOD VENTILATORY MUSCLE TRAINER | Sherwood Medical Co. | Sep 26, 1980 | SESE |
Top Applicants
- Sherwood Medical Co. — 1 clearance
- Global Business, Inc. — 1 clearance
