PRIMA HYUPERINFLATION SYSTEM
Device Facts
| Record ID | K952021 |
|---|---|
| Device Name | PRIMA HYUPERINFLATION SYSTEM |
| Applicant | Prima, Inc. |
| Product Code | BZR · Anesthesiology |
| Decision Date | May 22, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5330 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient.
