DATEX AS/3 TM ANAESTHESIA MONITOR
Device Facts
| Record ID | K933285 |
|---|---|
| Device Name | DATEX AS/3 TM ANAESTHESIA MONITOR |
| Applicant | Datex Division Instrumentarium Corp. |
| Product Code | BSZ · Anesthesiology |
| Decision Date | Nov 14, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5160 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).
