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510(k) K123614

SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS) by Trudell Medical Intl. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 2013
Date Received
November 23, 2012
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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  • 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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