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510(k) K244035

Portable mesh nebulizer (JM821) by Shenzhen Jermei Medical Device Technology Co., Ltd. — Product Code CAF

K244035 is an FDA 510(k) premarket notification submitted by Shenzhen Jermei Medical Device Technology Co., Ltd. for the device "Portable mesh nebulizer (JM821)". The FDA issued a decision of Substantially Equivalent on September 19, 2025. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2025
Date Received
December 30, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5630
Review Panel
AN
Submission Type

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FDA data resources