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510(k) K183108

Combined Aerobika OPEP and VersaPAP device by Trudell Medical International — Product Code BWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2019
Date Received
November 8, 2018
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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  • 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)
  • K182847 — Hudson RCI Voldyne Volumetric Exerciser (July 1, 2019)
  • K173918 — VersaPAP Positive Airway Pressure (PAP) Device (August 17, 2018)