MODIFICATION TO AIRLIFE HEATED VENTILATOR AND ANESTHESIA BREATHING CIRCUITS
Device Facts
| Record ID | K000697 |
|---|---|
| Device Name | MODIFICATION TO AIRLIFE HEATED VENTILATOR AND ANESTHESIA BREATHING CIRCUITS |
| Applicant | Allegiance Healthcare Corp. |
| Product Code | BZE · Anesthesiology |
| Decision Date | Mar 30, 2000 |
| Decision | SESE |
| Submission Type | Special |
| 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.
