Clearance Summary
COMPRESSOR NEBULIZER MODEL MCN-S600XX received FDA 510(k) clearance under submission number K123030, sponsored by Dongguan Aidisy Machinery & Electronic Equipment C. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2013-12-19.
- Submission: K123030
- Applicant / Sponsor: Dongguan Aidisy Machinery & Electronic Equipment C
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5630
- Decision date: 2013-12-19
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.