Clearance Summary
Ultrasonic Mesh Nebulizer received FDA 510(k) clearance under submission number K201397, sponsored by Shenzhen Ivankaca Technology 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 2021-06-14.
- Submission: K201397
- Applicant / Sponsor: Shenzhen Ivankaca Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5630
- Decision date: 2021-06-14
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.