← Product Code [MNR](/submissions/AN/subpart-c%E2%80%94monitoring-devices/MNR) · K233501

# “LARGAN Health AI-Tech” Sleep Apnea and Sleep Quality Examination System (ST-SLP03A) (K233501)

_Largan Medical Co., Ltd. · MNR · Jul 26, 2024 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/MNR/K233501

## Device Facts

- **Applicant:** Largan Medical Co., Ltd.
- **Product Code:** [MNR](/submissions/AN/subpart-c%E2%80%94monitoring-devices/MNR.md)
- **Decision Date:** Jul 26, 2024
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.2375
- **Device Class:** Class 2
- **Review Panel:** Anesthesiology

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/MNR/K233501](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/MNR/K233501)

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