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510(k) K133360

AERONEB SOLO; AERONEB SOLO ADAPTER by Aerogen, Ltd. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2014
Date Received
November 1, 2013
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 Aerogen, Ltd.

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  • 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)
  • K003022 — AERONEB PORTABLE NEBULIZER (October 13, 2000)
  • K992831 — AERONEB II, MODEL APN 200 (August 25, 2000)

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