510(k) clearance
Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210)
- 510(k) number
- K254171
- Applicant
- Shenzhen Mericonn Technology Co., Ltd.
- Decision date
- Sep 18, 2026
- Date received
- Dec 23, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- CAF
- Device type
- Nebulizer (Direct Patient Interface)
- Device class
- Class II
- Regulation
- 21 CFR 868.5630
- Advisory committee
- Anesthesiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Shenzhen, CN