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510(k) K021175

AERONEB PROFESSIONAL NEBULIZER SYSTEM, MODEL#AG-AP6000 by Aerogen, Inc. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2002
Date Received
April 12, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Aerogen, Inc.

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  • K120939 — AERONEB PRO (April 26, 2012)
  • K103635 — CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + SYRINGE: AG-AS3085; (May 13, 2011)
  • K032849 — AERONEB GO NEBULIZER, MODEL AG-AG2000 (November 21, 2003)
  • K003022 — AERONEB PORTABLE NEBULIZER (October 13, 2000)
  • K992831 — AERONEB II, MODEL APN 200 (August 25, 2000)

Other clearances for product code CAF

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  • K250583 — AdheResp Smart Breath-actuated Mesh Nebulizer (June 20, 2025)
  • K242354 — AllNEB (April 29, 2025)
  • 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)