LARGAN Health AI-Tech Sleep Apnea and Sleep Quality Examination System (ST-SLP03A)
Device Facts
| Record ID | K233501 |
|---|---|
| Device Name | LARGAN Health AI-Tech Sleep Apnea and Sleep Quality Examination System (ST-SLP03A) |
| Applicant | Largan Medical Co., Ltd. |
| Product Code | MNR · Anesthesiology |
| Decision Date | Jul 26, 2024 |
| 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.
