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510(k) K123400

AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE by Trudell Medical Intl. — Product Code BWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 2013
Date Received
November 5, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Therapeutic (Incentive)
Device Class
Class II
Regulation Number
868.5690
Review Panel
AN
Submission Type

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  • K110136 — RESPICHAMBER VALVED HOLDING CHAMBER (April 18, 2011)
  • K090065 — AEROCHAMBER MINI VENTILATION CHAMBER (April 9, 2009)
  • 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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