510(k) clearances

Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210)

Shenzhen Mericonn Technology Co., Ltd. · Anesthesiology

K254171Substantially EquivalentTraditionalCAF
Open FDA's page for this record
Third party flag
N
City
Shenzhen
Advisory committee description
Anesthesiology
Address 1
3/F, Bldg. 2, Tiantong Industrial Park, Gaofeng Community
Address 2
Dalang St., Longhua District
Statement or summary
Summary
Product code
CAF
Zip code
518109
Applicant
Shenzhen Mericonn Technology Co., Ltd.
Decision date
2026-09-18
Decision code
SESE
Country code
CN
Device name
Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210)
Advisory committee
AN
Contact
Chuanyuan Jiang
K number
K254171
Date received
2025-12-23
Review advisory committee
AN
Postal code
518109
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Nebulizer (Direct Patient Interface)
Medical specialty description
Anesthesiology
Regulation number
868.5630
Device class
2
Registration number
2954963, 8043439, 1417592, 9616354, 9617604, 3012971441, 3015219192, 3006157842, 8022890, 3006783791, 1314417, 3003767629, 3004748541, 3005669815, 3010272829, 3020638914, 9612777, 3007384659, 3003803075, 3004127293, 3023209222, 3032013079, 3007502289, 9710391, 3014499739, 3004365956, 3030733800, 3007344957, 9710644, 3017200972, 3009683397, 3034521, 3018782623, 3033482477, 3013530341, 9611045, 3006547005, 3004443928, 3009095356, 3011191255 +152 more
FEI number
1417592, 3003202124, 3012971441, 3015219192, 3006157842, 3006783791, 1314417, 1317628, 3003767629, 3004748541, 3005669815, 3010272829, 3020638914, 3007384659, 3003803075, 3004127293, 3023209222, 3032013079, 3007502289, 3014499739, 3004365956, 3030733800, 3002807674, 3017200972, 3007344957, 3009683397, 3033482477, 3013530341, 3006547005, 3004443928, 3009095356, 3011191255, 3016731115, 3001237796, 3001034529, 3006467300, 3030446844, 3010287621, 3015142935, 3004411059 +152 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.