K233501 is an FDA 510(k) clearance for the “LARGAN Health AI-Tech” Sleep Apnea and Sleep Quality Examination System (ST-SLP03A). This device is classified as a Ventilatory Effort Recorder (Class II - Special Controls, product code MNR).
Submitted by Largan Medical Co., Ltd. (Taichung, TW). The FDA issued a Cleared decision on July 26, 2024, 269 days after receiving the submission on October 31, 2023.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2375.
| 510(k) Number | K233501 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 31, 2023 |
| Decision Date | July 26, 2024 |
| Days to Decision | 269 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | MNR - Ventilatory Effort Recorder |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2375 |