Combined Aerobika OPEP and VersaPAP device— 510(k) K183108

Name: FDA 510(k) clearance K183108
Creator: U.S. Food and Drug Administration
Published: 2019-08-16

Substantially Equivalent

Trudell Medical International

FDA 510(k) clearance K183108 for Combined Aerobika OPEP and VersaPAP device, Substantially Equivalent on 2019-08-16. Applicant: Trudell Medical International. Device class: 2.

Clearance details

Applicant: Trudell Medical International
Product code: Code BWF
Device class: Class 2
Regulation: 21 CFR 868.5690
Advisory panel: Anesthesiology
Date received: 2018-11-08
Decision date: 2019-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: London, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code BWF

view all

K241152 — InSee2025-08-21
K233855 — AllPEP2024-02-02
K221058 — LungTrainer (MD2 & MD3)2023-07-05
K222018 — Breathe+2023-06-02
K220565 — Hudson RCI Triflo II Incentive Deep Breathing Exerciser2022-10-25

More clearances from Trudell Medical International

view all

K242667 — AeroChamber2go Anti-Static Valved Holding Chamber2025-01-15
K203400 — Corrugated tube with mouthpiece accessory2021-06-14
K200063 — AeroEclipse* ONE BAN2020-07-17
K181649 — AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC)2019-01-11
K173918 — VersaPAP Positive Airway Pressure (PAP) Device2018-08-17

Data sourced from openFDA. This site is unofficial and independent of the FDA.