Home / 510(k) Clearances / K012368

510(k) K012368

AEROPEP by Trudell Medical Intl. — Product Code BWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2002
Date Received
July 26, 2001
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

Other clearances by Trudell Medical Intl.

  • K131881 — OMBRA TABLE TOP COMPRESSOR (October 24, 2013)
  • K123400 — AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE (May 16, 2013)
  • K123614 — SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS) (March 11, 2013)
  • K112010 — AEROCHAMBER PLUS FLOW-VU ANTI-STATIC VALVED HOLDING CHAMBER (VHC) (July 11, 2012)
  • 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)

Other clearances for product code BWF

  • K241152 — InSee (August 21, 2025)
  • K233855 — AllPEP (February 2, 2024)
  • K221058 — LungTrainer (MD2 & MD3) (July 5, 2023)
  • K222018 — Breathe+ (June 2, 2023)
  • K220565 — Hudson RCI Triflo II Incentive Deep Breathing Exerciser (October 25, 2022)
  • K203378 — Pulsehaler (March 31, 2021)
  • K192000 — D R Burton OxyPAP (February 19, 2020)
  • K181660 — Acapella Choice Blue Vibratory PEP Device (October 24, 2019)
  • K183108 — Combined Aerobika OPEP and VersaPAP device (August 16, 2019)
  • K182847 — Hudson RCI Voldyne Volumetric Exerciser (July 1, 2019)