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510(k) K120939

AERONEB PRO by Aerogen, Ltd. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 2012
Date Received
March 29, 2012
Clearance Type
Special
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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  • K032849 — AERONEB GO NEBULIZER, MODEL AG-AG2000 (November 21, 2003)
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  • K003022 — AERONEB PORTABLE NEBULIZER (October 13, 2000)
  • K992831 — AERONEB II, MODEL APN 200 (August 25, 2000)

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  • K250583 — AdheResp Smart Breath-actuated Mesh Nebulizer (June 20, 2025)
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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)
  • K232523 — Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7% (April 10, 2024)