Clearance Summary
QUALITY LIFE TECHNOLOGIES COMPRESSOR NEBULIZER received FDA 510(k) clearance under submission number K112824, sponsored by Quality Life Technologies 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 2012-06-21.
- Submission: K112824
- Applicant / Sponsor: Quality Life Technologies Co;Ltd
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5630
- Decision date: 2012-06-21
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.