AirPhysio Positive Expiratory Pressure (PEP) Device
FDA 510(k) K203209 · Airphysio Pty, Ltd.
510(k) numberK203209
Submission
- Device name
- AirPhysio Positive Expiratory Pressure (PEP) Device
- Applicant
- Airphysio Pty, Ltd.
Tweed Heads South, AU - Received
- October 30, 2020
- Decision date
- January 15, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- BYI – Percussor, Powered-Electric
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5665
- Specialty
- Anesthesiology
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| K222496 | Electromed SmartVest Airway Clearance SystemBYI · Special | Electromed, Inc. | 11/18/2022SE |
| K201490 | Electro Flo 6 Airway Clearance SystemBYI · Traditional | Med Systems, Inc. | 02/12/2021SE |
| K173603 | Monarch Airway Clearance SystemBYI · Traditional | Hill-Rom Holdings, Inc. | 10/24/2018SE |
| K163378 | Monarch Airway Clearance SystemBYI · Traditional | Hill-Rom Services Pte, Ltd. | 03/17/2017SE |
| K142482 | The Vest Airway Clearance SystemBYI · Traditional | Hill-Rom Services Private Limited | 05/07/2015SE |
Questions and answers
When was AirPhysio Positive Expiratory Pressure (PEP) Device cleared by the FDA?
AirPhysio Positive Expiratory Pressure (PEP) Device (K203209) received a 510(k) decision of Substantially Equivalent on January 15, 2021, 77 days after the submission was received.
What is the product code of K203209?
The FDA product code is BYI – Percussor, Powered-Electric, a Class II (moderate risk) device regulated under 21 CFR 868.5665.