HALA'TUS 1 OXYGENATOR
Device Facts
| Record ID | K903504 |
|---|---|
| Device Name | HALA'TUS 1 OXYGENATOR |
| Applicant | The Henry G. Dietz Co., Inc. |
| Product Code | NFB · Anesthesiology |
| Decision Date | Jan 28, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5905 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.