ADDITION OF 50% OXYGEN TO APPLINC SAVING BREATH HY
Device Facts
| Record ID | K851245 |
|---|---|
| Device Name | ADDITION OF 50% OXYGEN TO APPLINC SAVING BREATH HY |
| Applicant | Applinc |
| Product Code | BZE · Anesthesiology |
| Decision Date | May 15, 1985 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5270 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A breathing system heater is a device that is intended to warm breathing gases before they enter a patient's airway. The device may include a temperature controller.