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510(k) K251659

Mesh Nebulizer (H6) by Qingdao Future Medical Technology Co., Ltd. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 2025
Date Received
May 30, 2025
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

Other clearances by Qingdao Future Medical Technology Co., Ltd.

  • K171549 — Intelligent Mesh Nebulizer (August 31, 2018)

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