DEMAND OXYGEN SAVER SYSTEM (D02S)
Device Facts
| Record ID | K861423 |
|---|---|
| Device Name | DEMAND OXYGEN SAVER SYSTEM (D02S) |
| Applicant | Applied Membrane Technology, Inc. |
| Product Code | BZQ · Anesthesiology |
| Decision Date | May 16, 1986 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.2375 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.
