PRESSURIZER
Device Facts
| Record ID | K951988 |
|---|---|
| Device Name | PRESSURIZER |
| Applicant | Promedic, Inc. |
| Product Code | KZD · General Hospital |
| Decision Date | Jun 14, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5420 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A pressure infusor for an I.V. bag is a device consisting of an inflatable cuff which is placed around an I.V. bag. When the device is inflated, it increases the pressure on the I.V. bag to assist the infusion of the fluid.
