Aerobika OPEP Devive with Manometer
FDA 510(k) K150173 · Trudell Medical International
510(k) numberK150173
Submission
- Device name
- Aerobika OPEP Devive with Manometer
- Applicant
- Trudell Medical International
London, CA - Received
- January 26, 2015
- Decision date
- October 15, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BWF – Spirometer, Therapeutic (Incentive)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5690
- Specialty
- Anesthesiology
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| K233855 | AllPEPBWF · Traditional | Enchant Tek Co. , Ltd. | 02/02/2024SE |
| K221058 | LungTrainer (MD2 & MD3)BWF · Traditional | Lung Trainers, LLC | 07/05/2023SE |
| K222018 | Breathe+BWF · Traditional | Peep Medical, LLC Dba Go2 Devices | 06/02/2023SE |
| K220565 | Hudson RCI Triflo II Incentive Deep Breathing ExerciserBWF · Traditional | Medline Industries, Inc. | 10/25/2022SE |
| K203378 | PulsehalerBWF · Traditional | Respinova, Ltd. | 03/31/2021SE |
| K192000 | D R Burton OxyPAPBWF · Traditional | D R Burton Healthcare, LLC | 02/19/2020SE |
| K181660 | Acapella Choice Blue Vibratory PEP DeviceBWF · Traditional | Smiths Medical | 10/24/2019SE |
| K183108 | Combined Aerobika OPEP and VersaPAP deviceBWF · Traditional | Trudell Medical International | 08/16/2019SE |
| K182847 | Hudson RCI Voldyne Volumetric ExerciserBWF · Traditional | Teleflexmedical, Inc. | 07/01/2019SE |
More from Teleflexmedical, Inc.
| 510(k) | Device | Decision |
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| K242667 | AeroChamber2go Anti-Static Valved Holding ChamberNVP · Traditional | 01/15/2025SE |
| K203400 | Corrugated tube with mouthpiece accessoryCAF · Traditional | 06/14/2021SE |
| K200063 | AeroEclipse* ONE BANCAF · Abbreviated | 07/17/2020SE |
| K183108 | Combined Aerobika OPEP and VersaPAP deviceBWF · Traditional | 08/16/2019SE |
| K181649 | AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC)NVP · Traditional | 01/11/2019SE |
| K173918 | VersaPAP Positive Airway Pressure (PAP) DeviceBWF · Traditional | 08/17/2018SE |
| K173825 | MC 300R* NebulizerCAF · Traditional | 05/02/2018SE |
| K173367 | MC 300* NebulizerCAF · Traditional | 02/28/2018SE |
Questions and answers
When was Aerobika OPEP Devive with Manometer cleared by the FDA?
Aerobika OPEP Devive with Manometer (K150173) received a 510(k) decision of Substantially Equivalent on October 15, 2015, 262 days after the submission was received.
What is the product code of K150173?
The FDA product code is BWF – Spirometer, Therapeutic (Incentive), a Class II (moderate risk) device regulated under 21 CFR 868.5690.