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510(k) K101136

FISIO CHAMBER SPACE by Koo (Shanghai) Industries Co., Ltd. — Product Code NVP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 2011
Date Received
April 22, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Holding Chambers, Direct Patient Interface
Device Class
Class II
Regulation Number
868.5630
Review Panel
AN
Submission Type

Holding chambers are devices that are used with nebulizers and metered dose inhalers and are comprised of a reservoir into which an aerosol medication is dispensed. A holding chamber uses a valved mouthpiece through which the patient inhales the dispensed medication. Holding chambers are intended to minimize delivery of large aerosolized particles

Other clearances by Koo (Shanghai) Industries Co., Ltd.

  • K112041 — KOO SMALL VOLUME NEBULIZER (SVN) (December 22, 2011)

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  • K122252 — SPACE CHAMBER PLUS COMPACT SPACE CHAMBER PLUS (November 13, 2013)
  • K130598 — INSPIRACHAMBER ANTI-STATIC VALVED HOLDING CHAMBER (June 5, 2013)
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  • K110293 — OPTICHAMBER DIAMOND VALVED HOLDING CHAMBER (August 9, 2011)