510(k) K233501
K233501 is an FDA 510(k) premarket notification submitted by Largan Medical Co., Ltd. for the device "LARGAN Health AI-Tech Sleep Apnea and Sleep Quality Examination System (ST-SLP03A)". The FDA issued a decision of Substantially Equivalent on July 26, 2024. The device falls under product code MNR (Ventilatory Effort Recorder), a Class II device regulated under 21 CFR 868.2375. Largan Medical Co., Ltd. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 26, 2024
- Date Received
- October 31, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilatory Effort Recorder
- Device Class
- Class II
- Regulation Number
- 868.2375
- Review Panel
- AN
- Submission Type