Clearance Summary
ULTRASONIC NEBULIZER (MESH TYPE) received FDA 510(k) clearance under submission number K121520, sponsored by K-Jump Health Co., Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2013-03-15.
- Submission: K121520
- Applicant / Sponsor: K-Jump Health Co., Ltd.
- Clearance pathway: Abbreviated
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5630
- Decision date: 2013-03-15
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.