MODEL# 7500 SURVEYOR
Device Facts
| Record ID | K944611 |
|---|---|
| Device Name | MODEL# 7500 SURVEYOR |
| Applicant | Devilbiss Health Care, Inc. |
| Product Code | MNR · Anesthesiology |
| Decision Date | Apr 21, 1995 |
| 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.