NITRONOX(R), FIRST RESPONSE NITRONOX(TM)
Device Facts
| Record ID | K883833 |
|---|---|
| Device Name | NITRONOX(R), FIRST RESPONSE NITRONOX(TM) |
| Applicant | Matrix Medica, Inc. |
| Product Code | BZR · Anesthesiology |
| Decision Date | Feb 17, 1989 |
| 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.