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510(k) K192633

GUS831 Compressor Nebulizer by Globalcare Medical Technology Co., Ltd. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2020
Date Received
September 23, 2019
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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  • K233553 — MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter (June 18, 2024)
  • K232507 — Aerogen®Solo Nebulizer System (May 10, 2024)
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