K233501
- 510(k) number
- K233501
- Device name
- LARGAN Health AI-Tech Sleep Apnea and Sleep Quality Examination System (ST-SLP03A)
- Applicant
- Largan Medical Co., Ltd. TW
- Product code
- MNR — Ventilatory Effort Recorder
- Decision date
- 2024-07-26
- Date received
- 2023-10-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
510(k) Summary (official FDA PDF): K233501.pdf
Official FDA record: K233501
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.