AirPhysio Positive Expiratory Pressure (PEP) Device— 510(k) K203209

Substantially Equivalent

Airphysio Pty, Ltd.

FDA 510(k) clearance K203209 for AirPhysio Positive Expiratory Pressure (PEP) Device, Substantially Equivalent on 2021-01-15. Applicant: Airphysio Pty, Ltd..

Clearance details

Applicant: Airphysio Pty, Ltd.
Product code: Code BYI
Advisory panel: Anesthesiology
Date received: 2020-10-30
Decision date: 2021-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tweed Heads South, AU

Download summary PDF View on FDA.gov ↗

Adverse events under product code BYI

product code BYI

Death: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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