VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYS
Device Facts
| Record ID | K864822 |
|---|---|
| Device Name | VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYS |
| Applicant | Surgidyne, Inc. |
| Product Code | BTC · Anesthesiology |
| Decision Date | Jan 15, 1987 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5320 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A reservoir bag is a device, usually made of conductive rubber, intended for use in a breathing circuit as a reservoir for breathing gas and to assist, control, or monitor a patient's ventilation.