Clearance Summary
Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103) received FDA 510(k) clearance under submission number K243468, sponsored by Joytech Healthcare 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 2025-07-02.
- Submission: K243468
- Applicant / Sponsor: Joytech Healthcare Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5630
- Decision date: 2025-07-02
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.