Clearance Summary
AllNEB received FDA 510(k) clearance under submission number K242354, sponsored by Enchant Tek Co. , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2025-04-29.
- Submission: K242354
- Applicant / Sponsor: Enchant Tek Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5630
- Decision date: 2025-04-29
Classification & Regulation
This clearance is catalogued under FDA product code CAF and 21 CFR 868.5630, within the Anesthesiology review panel as a Class II device.