Home / 510(k) Clearances / K080100

510(k) K080100

WATCHHALER by Activaero America, Inc. — Product Code NVP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 2008
Date Received
January 14, 2008
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 Activaero America, Inc.

  • K090730 — AKITA JET (November 13, 2009)
  • K072019 — AKITA2 APIXNEB (November 5, 2007)

Other clearances for product code NVP

  • K242667 — AeroChamber2go Anti-Static Valved Holding Chamber (January 15, 2025)
  • K210558 — LiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber (April 1, 2022)
  • K181649 — AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC) (January 11, 2019)
  • K160109 — Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber (May 19, 2017)
  • K143615 — Antistatic Compact Space Chamber (January 26, 2016)
  • K140062 — FSC ANTI-STATIC VALVED COLLAPSIBLE HOLDING CHAMBER (October 3, 2014)
  • K122252 — SPACE CHAMBER PLUS COMPACT SPACE CHAMBER PLUS (November 13, 2013)
  • K130598 — INSPIRACHAMBER ANTI-STATIC VALVED HOLDING CHAMBER (June 5, 2013)
  • K112010 — AEROCHAMBER PLUS FLOW-VU ANTI-STATIC VALVED HOLDING CHAMBER (VHC) (July 11, 2012)
  • K110293 — OPTICHAMBER DIAMOND VALVED HOLDING CHAMBER (August 9, 2011)