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510(k) K090065

AEROCHAMBER MINI VENTILATION CHAMBER by Trudell Medical Intl. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 2009
Date Received
January 9, 2009
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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  • K110136 — RESPICHAMBER VALVED HOLDING CHAMBER (April 18, 2011)
  • K080926 — AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER (August 12, 2008)
  • K070674 — AEROCHAMBER PLUS ANTI-STATIC VALVED HOLDING CHAMBER WITH FLOW-VU INSPIRATORY FLO (April 11, 2007)
  • K053605 — AEROECLIPSE II BREATH ACTUATED NEBULIZER (February 27, 2006)
  • K052332 — AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBER (September 21, 2005)
  • K032972 — AEROCHAMBER MAX VALVED HOLDING CHAMBER (January 14, 2004)

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