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510(k) K003022

AERONEB PORTABLE NEBULIZER by Aerogen, Inc. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 2000
Date Received
September 28, 2000
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)
  • K021175 — AERONEB PROFESSIONAL NEBULIZER SYSTEM, MODEL#AG-AP6000 (May 15, 2002)
  • K992831 — AERONEB II, MODEL APN 200 (August 25, 2000)

Other clearances for product code CAF

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  • K243468 — Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebul (July 2, 2025)
  • K250022 — HeroTracker Sense (June 30, 2025)
  • 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)