LARGAN Health AI-Tech Sleep Apnea and Sleep Quality Examination System (ST-SLP03A)— 510(k) K233501
Substantially EquivalentLargan Medical Co., Ltd.
FDA 510(k) clearance K233501 for LARGAN Health AI-Tech Sleep Apnea and Sleep Quality Examination System (ST-SLP03A), Substantially Equivalent on 2024-07-26. Applicant: Largan Medical Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Largan Medical Co., Ltd.
- Product code
- Code MNR
- Device class
- Class 2
- Regulation
- 21 CFR 868.2375
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Taichung, TW
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Data sourced from openFDA. This site is unofficial and independent of the FDA.